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Trial record 1 of 1 for:    REP0112
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Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01967888
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : October 9, 2019
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pancreatectomy for Chronic Pancreatitis
Interventions Drug: Reparixin
Drug: Placebo
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Period Title: Overall Study
Started 52 52
Completed 42 45
Not Completed 10 7
Reason Not Completed
Lost to Follow-up             6             4
Withdrawal by Subject             1             1
Did Not Have Transplant             1             0
Research visit not done, data recorded             1             0
Subject excluded after randomization             1             0
Patient didn't proceed to pancreatectomy             0             1
Subject Unable To Comply With Final Day             0             1
Arm/Group Title Reparixin Placebo Total
Hide Arm/Group Description

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Total of all reporting groups
Overall Number of Baseline Participants 50 52 102
Hide Baseline Analysis Population Description
Two patients initially randomised to Reparixin received no treatment, hence were not included in the in the population analysed for demographics
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
<=18 years
2
   4.0%
0
   0.0%
2
   2.0%
Between 18 and 65 years
46
  92.0%
52
 100.0%
98
  96.1%
>=65 years
2
   4.0%
0
   0.0%
2
   2.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 102 participants
40.0  (14.4) 39.0  (10.0) 39.5  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Female
33
  66.0%
38
  73.1%
71
  69.6%
Male
17
  34.0%
14
  26.9%
31
  30.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Hispanic or Latino
1
   2.0%
3
   5.8%
4
   3.9%
Not Hispanic or Latino
49
  98.0%
49
  94.2%
98
  96.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 102 participants
Canada 4 3 7
United States 46 49 95
1.Primary Outcome
Title Percentage of Patients Who Were Insulin Independent After Islet Autotransplantation (IAT) at Day 365±14 Days After Transplant.
Hide Description

Insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycemic control, as defined by:

  • a glycated hemoglobin (HbA1c) level <6.5%;
  • fingerstick fasting blood glucose not exceeding 126 mg/dL more than three times in the past week (based on a minimum of one daily measurement;
  • a 2 hour post-prandial blood glucose not exceeding 180 mg/dL more than four times in the past week (based on a minimum of one daily measurement);
  • a laboratory fasting glucose in the non-diabetic range (<126 mg/dL).
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Measure Type: Number
Unit of Measure: Percentage of participants
20.0 21.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.542
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter t-test
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-14.3 to 000
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Area Under the Curve (AUC) for the Serum C-peptide Level at Day 75±14 After the Transplant
Hide Description AUC for the serum C-peptide level is calculated during the first 4 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 43 48
Mean (Standard Deviation)
Unit of Measure: (ng/mL)/(IEQ/kg)*1000
0.5314796  (0.3520819) 0.6827533  (0.4769178)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.1601778
Confidence Interval (2-Sided) 95%
-0.3178030 to -0.0025525
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Curve (AUC) for the Serum C-peptide Level at Day 365±14 After the Transplant
Hide Description AUC for the serum C-peptide level is calculated during the first 4 hours of a mixed meal tolerance test (MMTT), normalized by the number of Islet Equivalent (IEQ)/kg
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 33 41
Mean (Standard Deviation)
Unit of Measure: (ng/mL)/(IEQ/kg)*1000
0.5563432  (0.3133415) 0.6865954  (0.4464460)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.1178242
Confidence Interval (2-Sided) 95%
-0.2874310 to 0.0517825
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Average Daily Insulin Requirements at Day 75±14 After the Transplant
Hide Description Daily insulin is reported as IU/kg and intake averaged over the previous week.
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 44 49
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.2125  (0.1643) 0.2190  (0.1589)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.846
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 0.0136
Confidence Interval (2-Sided) 95%
-0.0508 to 0.0781
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Average Daily Insulin Requirements at Day 365±14 After the Transplant
Hide Description Daily insulin is reported as IU/kg and intake averaged over the previous week.
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 39 43
Mean (Standard Deviation)
Unit of Measure: IU/kg/day
0.1723  (0.1893) 0.1823  (0.1994)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.025
Confidence Interval (2-Sided) 95%
-0.0939 to 0.0689
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant
Hide Description

Data of this outcome are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
  • 15 min; N=42; 46
  • 30 min; N=40; 46
  • 60 min; N=40; 46
  • 90 min; N=40; 46
  • 120 min; N=41; 46
  • 180 min; N=40; 46
  • 240 min; N=39; 44
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
157.0894  (11.98160) 166.5535  (11.45706)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.570
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -9.4641
Confidence Interval (2-Sided) 95%
-42.4900 to 23.5618
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant
Hide Description

Data are reported as "model estimates over all timepoints"

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=34; 42 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
  • 15 min; N=34; 41
  • 30 min; N=34; 41
  • 60 min; N=34; 41
  • 90 min; N=34; 41
  • 120 min; N=34; 41
  • 180 min; N=33; 41
  • 240 min; N=33; 41
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
157.9988  (12.00455) 180.9442  (12.08647)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.074
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -22.9454
Confidence Interval (2-Sided) 95%
-48.1826 to 2.2918
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant
Hide Description

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=44; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
  • 15 min; N=43; 47
  • 30 min; N=41; 47
  • 60 min; N=42; 47
  • 90 min; N=42; 47
  • 120 min; N=42; 47
  • 180 min; N=41; 47
  • 240 min; N=40; 44
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
1.8976  (0.20787) 2.1051  (0.20104)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.358
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.2074
Confidence Interval (2-Sided) 95%
-0.6538 to 0.2389
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant
Hide Description

Data are reported as "model estimates over all timepoints".

This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=33; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
  • 15 min; N=34; 41
  • 30 min; N=34; 41
  • 60 min; N=33; 41
  • 90 min; N=34; 41
  • 120 min; N=34; 41
  • 180 min; N=33; 40
  • 240 min; N=33; 41
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: ng/mL
1.6052  (0.24507) 1.8822  (0.24763)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.288
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value -0.2770
Confidence Interval (2-Sided) 95%
-0.7936 to 0.2396
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant
Hide Description

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).
  • 15 min; N=43; 47
  • 30 min; N=41; 47
  • 60 min; N=41; 47
  • 90 min; N=41; 47
  • 120 min; N=42; 47
  • 180 min; N=41; 47
  • 240 min; N=40; 44
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: UIU/mL
23.67209  (3.497499) 23.57493  (3.378854)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.980
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 0.09716
Confidence Interval (2-Sided) 95%
-7.41834 to 7.61266
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant
Hide Description

Data are reported as "model estimates over all timepoints".

This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • basal; N=34; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal)
  • 15 min; N=34; 41
  • 30 min; N=34; 41
  • 60 min; N=34; 41
  • 90 min; N=34; 41
  • 120 min; N=34; 41
  • 180 min; N=33; 41
  • 240 min; N=33; 40
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: UIU/mL
22.85522  (3.718512) 21.77905  (3.757573)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.785
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 1.07617
Confidence Interval (2-Sided) 95%
-6.76562 to 8.91796
Estimation Comments [Not Specified]
12.Secondary Outcome
Title β-cell Function at Day 75±14 After the Transplant
Hide Description

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for:

  • fasting plasma glucose,
  • HbA1c,
  • stimulated C-peptide
  • insulin requirement subscales. The higher the total score, the better the outcome.
  • Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
  • HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
  • Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
  • Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 42 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
5.7  (1.6) 5.2  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title β-cell Function at Day 365±14 After the Transplant
Hide Description

This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for glucose, HbA1c, stimulated C-peptide and insulin requirement subscales.

The higher the total score the better the outcome.

  • Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)
  • HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)
  • Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)
  • Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 32 41
Median (Standard Deviation)
Unit of Measure: score on a scale
5.9  (2.0) 5.4  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant
Hide Description Percentage of patients with a glycated haemoglobin (HbA1c) <6.5% at day 365±14 after the transplant.
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 42 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.3
(49.79 to 78.78)
62.2
(48.06 to 76.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-18.20 to 22.33
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Cumulative Number of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant
Hide Description A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.
Time Frame from day 75±14 to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 41 44
Mean (Standard Deviation)
Unit of Measure: number of events
0.1  (0.94) 0.0  (0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments [Not Specified]
Method Anderson-Gill model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.21
Confidence Interval (2-Sided) 95%
0.29 to 34.97
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant AND Free of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant Inclusive
Hide Description Percentage of patients with an HbA1c <6.5% at day 365±14 after the transplant AND free of severe hypoglycemic events from day 75±14 to day 365±14 after the transplant inclusive.A severe hypoglycemic event is defined as an event with one of the following symptoms: "memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms", in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.
Time Frame from day 75±14 to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 39 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.1
(49.05 to 79.16)
59.1
(44.56 to 73.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment effect
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
-15.91 to 25.93
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study
Hide Description

The percentages of patients with any treatment emergent adverse events (TEAE, serious and non serious) and with serious TEAE by severity are presented.

Patients with multiple events within a particular system organ class or preferred term were counted only under the category of their most severe event within that system organ class or preferred term.

A serious AE was defined as any untoward medical occurrence that at any dose:

  • Resulted in death
  • Was life-threatening (ie, the patient was at risk of death at the time of the event)
  • Required inpatient hospitalization or prolongation of existing hospitalization
  • Resulted in persistent or significant disability/incapacity
  • Was a congenital anomaly/birth defect
  • Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above
Time Frame up to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description

ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.

Eligible patients are included in this population whether or not they receive IAT.

Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Measure Type: Number
Unit of Measure: percentage of patients
TEAE- Mild events 90.0 92.3
TEAE - Moderate events 90.0 80.8
TEAE - Severe events 64.0 53.8
serious TEAE- Mild events 18.0 23.1
serious TEAE- Moderate events 22.0 13.5
serious TEAE- Severe events 42.0 32.7
18.Secondary Outcome
Title Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant
Hide Description

Malnutrition risk levels are defined as:

  • Poor prognosis = pre-albumin level <5.0 mg/dL
  • Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
  • Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
  • Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 42 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
poor prognosis
0
(0.00 to 8.41)
0
(0.00 to 7.71)
significant risk
9.5
(2.66 to 22.62)
4.3
(0.53 to 14.84)
increased risk
45.2
(29.85 to 61.33)
28.3
(15.99 to 43.46)
normal
45.2
(29.85 to 61.33)
67.4
(51.98 to 80.47)
19.Secondary Outcome
Title Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant
Hide Description

Malnutrition risk levels are defined as:

  • Poor prognosis = pre-albumin level <5.0 mg/dL
  • Significant risk = pre-albumin level 5.0 to 10.9 mg/dL
  • Increased risk = pre-albumin level 11.0 to 15.0 mg/dL
  • Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 40 44
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Poor prognosis
5.0
(0.61 to 16.92)
0
(0.00 to 8.04)
Significant risk
2.5
(0.06 to 13.16)
6.8
(1.43 to 18.66)
Increased risk
27.5
(14.60 to 43.89)
9.1
(2.53 to 21.67)
Normal
65.0
(48.32 to 79.37)
84.1
(69.93 to 93.36)
20.Secondary Outcome
Title Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant
Hide Description

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

  • No steatorrhea;
  • Steatorrhea few times per week;
  • Steatorrhea daily;
  • Stool incontinence.
Time Frame day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 44 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
no steatorrhea
54.5
(38.85 to 69.61)
64.6
(49.46 to 77.84)
steatorrhea few times per week
29.5
(16.76 to 45.20)
25.0
(13.64 to 39.60)
steatorrhea daily
11.4
(3.79 to 24.56)
6.3
(1.31 to 17.20)
stool incontinence
4.5
(0.56 to 15.47)
4.2
(0.51 to 14.25)
21.Secondary Outcome
Title Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant
Hide Description

Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:

  • No steatorrhea;
  • Steatorrhea few times per week;
  • Steatorrhea daily;
  • Stool incontinence.
Time Frame day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 42 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
no steatorrhea
52.4
(36.42 to 68.00)
58.7
(43.23 to 73.00)
steatorrhea few times per week
26.2
(13.86 to 42.04)
19.6
(9.36 to 33.91)
steatorrhea daily
21.4
(10.30 to 36.81)
21.7
(10.95 to 36.36)
stool incontinence
0
(0.00 to 8.41)
0
(0.00 to 7.71)
22.Secondary Outcome
Title Cumulative Number of Episodes of Documented Asymptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant
Hide Description

The following definition applies:

- Asymptomatic hypoglycemia = An event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <70mg/dL.

Time Frame from day 75±14 to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 41 45
Mean (Standard Deviation)
Unit of Measure: number of episodes
1.5  (4.3) 4.4  (25.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
23.Secondary Outcome
Title Cumulative Number of Episodes of Documented Symptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant
Hide Description

The following definition applies:

- Documented symptomatic hypoglycemia = An event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <70mg/dL.

Time Frame from day 75±14 to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 41 45
Mean (Standard Deviation)
Unit of Measure: number of episodes
4.6  (13.9) 4.8  (17.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
24.Secondary Outcome
Title Cumulative Number of Diabetic Ketoacidosis-related Events
Hide Description

A diabetic ketoacidosis event is defined as the presence of:

  • hyperglycemia (blood glucose >200 mg/dL);
  • pH <7.3 or HCO3 <15;
  • ketones positive in the serum or urine.
Time Frame from day 75±14 to day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 41 46
Mean (Standard Deviation)
Unit of Measure: number of events
0.0  (0.0) 0.0  (0.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
25.Secondary Outcome
Title Peak C-peptide at Day 75 After the Transplant
Hide Description Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.
Time Frame Day 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 44 48
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.640  (1.529) 2.900  (1.753)
26.Secondary Outcome
Title Peak C-peptide at Day 365 After the Transplant
Hide Description Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.
Time Frame Day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 34 41
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.630  (1.467) 3.170  (1.843)
27.Secondary Outcome
Title Time-to-peak C-peptide at Day 75 After the Transplant
Hide Description The time-to-peak value in minutes was computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test Case Report Form.
Time Frame day 75±14 and day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 43 44
Mean (Standard Deviation)
Unit of Measure: minutes
104.2  (93.6) 108.7  (59.4)
28.Secondary Outcome
Title Time-to-peak C-peptide at Day 365 After the Transplant
Hide Description The time to peak value in minutes will be computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test CRF.
Time Frame Day 365±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 31 40
Mean (Standard Deviation)
Unit of Measure: minutes
97.8  (90.9) 102.0  (56.2)
29.Secondary Outcome
Title Change From Baseline in Post-transplant Alanine Aminotransferase (ALT)
Hide Description

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • baseline; N=50; 52
  • Day 2 post-transplant; N=49; 51
  • Day 3 post-transplant; N=47; 50
  • Day 7 post-transplant; N=47; 50
  • Day 75 post-transplant; N=44; 47
Time Frame Baseline, Days 2, 3, 7, 75 ±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: U/L
60.4105  (40.9699) 29.0615  (40.2724)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.5018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least square mean difference
Estimated Value 31.3491
Confidence Interval (2-Sided) 95%
-60.9980 to 123.70
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in Post-transplant Aspartate Aminotransferase (AST)
Hide Description

Data are reported as "model estimates over all timepoints".

This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:

  • baseline; N=50; 52
  • Day 2 post-transplant; N=49; 51
  • Day 3 post-transplant; N=47; 50
  • Day 7 post-transplant; N=47; 50
  • Day 75 post-transplant; N=44; 47
Time Frame Baseline, Days 2, 3, 7, 75±14 after the transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Least Squares Mean (Standard Error)
Unit of Measure: U/L
46.8755  (27.8248) 23.3301  (26.6545)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reparixin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.4537
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 23.5454
Confidence Interval (2-Sided) 95%
-38.6619 to 85.7528
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Number of Treatment Emergent Adverse Events Related to Investigational Product
Hide Description

Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called "Adverse reactions" (ADR).

An adverse reaction is defined as any untoward medical occurrence in a patient or clinical investigation patient, which has a causal relationship with the administered medicinal product.

Time Frame Throughout the study From Day -1 to hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population:Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Measure Type: Number
Unit of Measure: Number of events
possibly related 20 28
probably related 0 0
highly probably related 0 0
32.Secondary Outcome
Title Number of Serious Treatment Emergent Adverse Events Related to Investigational Product
Hide Description

Serious Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called serious "Adverse reactions".

A serious adverse reaction is defined as any untoward medical occurrence with a causal relationship with the administered medicinal product, that at any dose:

  • Resulted in death
  • Was life-threatening (ie, the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)
  • Required patient hospitalization or prolongation of existing hospitalization
  • Resulted in persistent or significant disability/incapacity
  • Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above
Time Frame Throughout the study From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population were based on treatment received. Patients randomized but not treated were analyzed in the total summary statistics only.
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description:

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

Overall Number of Participants Analyzed 50 52
Measure Type: Number
Unit of Measure: Number of events
possibly related 4 1
probably related 0 0
highly probably related 0 0
Time Frame From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reparixin Placebo
Hide Arm/Group Description

Solution for intravenous (IV) infusion with active compound

Reparixin: Solution for intravenous (IV) infusion; 2.772 mg/kg body weight/hour administered at 0.25 mL/kg/hour

Physiologic solution

Placebo: Physiologic solution administered at 0.25 mL/kg/hour

All-Cause Mortality
Reparixin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/52 (0.00%)    
Hide Serious Adverse Events
Reparixin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/50 (58.00%)      30/52 (57.69%)    
Blood and lymphatic system disorders     
Leucocytosis  1  1/50 (2.00%)  1 1/52 (1.92%)  2
Cardiac disorders     
Sinus tachycardia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Eye disorders     
Eye pain  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Visual impairment  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  13/50 (26.00%)  22 7/52 (13.46%)  19
Vomiting  1  4/50 (8.00%)  4 4/52 (7.69%)  7
Nausea  1  3/50 (6.00%)  4 4/52 (7.69%)  10
small intestinal obstruction  1  2/50 (4.00%)  2 4/52 (7.69%)  4
Diarrhoea  1  0/50 (0.00%)  0 3/52 (5.77%)  8
abdominal hernia  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Colitis  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Intra-abdominal fluid collection  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Abdominal pain lower  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Ascites  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Constipation  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Enteritis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Faecaloma  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastritis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Gastrointestinal Haemorrage  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Gastrintestinal necrosis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
impaired gastric empting  1  1/50 (2.00%)  1 0/52 (0.00%)  0
intestinal ischeamia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
omental infarction  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Upper gastrointestinal haemorrhage  1  1/50 (2.00%)  1 0/52 (0.00%)  0
General disorders     
Pyrexia  1  3/50 (6.00%)  3 1/52 (1.92%)  2
Hernia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Malaise  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Oedema peripheral  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Peripheral swelling  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Vascular stent occlusion  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hepatobiliary disorders     
Hepatic function abnormal  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Portal vein thrombosis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Infections and infestations     
Pneumonia  1  3/50 (6.00%)  3 1/52 (1.92%)  1
Urinary tract infections  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Clostridium difficile infection  1  2/50 (4.00%)  3 0/52 (0.00%)  0
Clostridium difficile colitis  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Postoperative wound infection  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Sepsis  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Gastrenteritis viral  1  0/50 (0.00%)  0 1/52 (1.92%)  2
Bacterial infection  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Biliary tract infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Cellulitis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastroenteritis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
gastrointestinal infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Influenza  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Joint abscess  1  0/50 (0.00%)  0 1/52 (1.92%)  1
postoperative abscess  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Urosepsis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Viral infection  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Wound infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications     
Anastomotic ulcer  1  0/50 (0.00%)  0 4/52 (7.69%)  4
Accidental overdose  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Incisional hernia  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Arterial injury  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastroparesis postoperative  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Post procedural haemorrhage  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Post operative hernia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Seroma  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Vascular graft stenosis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Wound complication  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Investigations     
Transaminases increased  1  2/50 (4.00%)  3 0/52 (0.00%)  0
Hepatic enzyme increased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  2/50 (4.00%)  6 2/52 (3.85%)  4
Malnutrition  1  1/50 (2.00%)  1 2/52 (3.85%)  3
Hyperglycaemia  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Hypoglycaemia  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Diabetes mellitus inadequate control  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Failure to thrive  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Hypercalaemia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Osteoarthritis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid cancer  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders     
Depressed levele of consciousness  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Migrane  1  0/50 (0.00%)  0 1/52 (1.92%)  2
Lethargy  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Syncope  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Psychiatric disorders     
Mental status changes  1  1/50 (2.00%)  2 0/52 (0.00%)  0
Confusion of state  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Pulmonary embolism  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Atelectasis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Pleuritic pain  1  1/50 (2.00%)  1 0/52 (0.00%)  0
respiratory failure  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Vascular disorders     
Hypotension  1  2/50 (4.00%)  2 0/52 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Reparixin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/50 (92.00%)      48/52 (92.31%)    
Blood and lymphatic system disorders     
Anaemia  1  25/50 (50.00%)  25 22/52 (42.31%)  22
Leukocytosis  1  4/50 (8.00%)  4 1/52 (1.92%)  1
Thrombocytosis  1  3/50 (6.00%)  3 1/52 (1.92%)  1
Iron deficiency anaemia  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Coagulopathy  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Haemorragic anaemia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Thrombocytopenia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Cardiac disorders     
Thachycardia  1  4/50 (8.00%)  4 9/52 (17.31%)  9
Sinus tachycardia  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Angina pectoris  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  19/50 (38.00%)  26 21/52 (40.38%)  21
Abdominal pain  1  8/50 (16.00%)  10 3/52 (5.77%)  3
Constipation  1  11/50 (22.00%)  11 16/52 (30.77%)  16
Vomiting  1  8/50 (16.00%)  8 7/52 (13.46%)  7
Diarrhoea  1  4/50 (8.00%)  4 3/52 (5.77%)  3
Gastrooesophageal reflux disease  1  3/50 (6.00%)  3 2/52 (3.85%)  2
Abdominal distension  1  1/50 (2.00%)  1 3/52 (5.77%)  3
Abdominal pain upper  1  2/50 (4.00%)  3 1/52 (1.92%)  1
Ascites  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Dyspepsia  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Flatulence  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Ileus  1  3/50 (6.00%)  3 0/52 (0.00%)  0
Gastrointestinal haemorrhage  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Intra-abdominal haemorrhage  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Abdominal rigidity  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Bile acid malabsorption  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Gastrointestinal pain  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hypoaesthesia oral  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Jejunal ulcer  1  1/50 (2.00%)  1 0/52 (0.00%)  0
mesenteric artery trhombosis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Peptic ulcer  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Pneumatosis intestinalis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Stomatitis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
General disorders     
Pyrexia  1  10/50 (20.00%)  13 10/52 (19.23%)  11
Oedema peripheral  1  1/50 (2.00%)  1 3/52 (5.77%)  3
Pain  1  2/50 (4.00%)  3 2/52 (3.85%)  2
Non-cardiac chest pain  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Asthenia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Breackthrough pain  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Chills  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Generalized oedema  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Secretion discharge  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Hepatobiliary disorders     
Portal vein thrombosis  1  3/50 (6.00%)  3 0/52 (0.00%)  0
Hepatitis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hyperbilirubinaemia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations     
Urinary tract infection  1  2/50 (4.00%)  2 5/52 (9.62%)  5
Penumonia  1  0/50 (0.00%)  0 4/52 (7.69%)  4
Clostridium difficile infection  1  3/50 (6.00%)  3 2/52 (3.85%)  2
Clostridium difficile colitis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Infection  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Abdominal infection  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Cellulitis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Candida infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Escherichia urinary tract infection  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Fungal infection  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Gastroenteritis clostridial  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Genital herpes  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Respiratory moniliasis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Urinary tract infection fungal  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Vaginal infection  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Wound infection fungal  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications     
Procedural pain  1  37/50 (74.00%)  37 43/52 (82.69%)  43
Incision site pain  1  5/50 (10.00%)  7 2/52 (3.85%)  3
Procedural nausea  1  2/50 (4.00%)  2 4/52 (7.69%)  4
Accidental overdose  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Seroma  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Anaemia postoperative  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Procedural hypotension  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Procedural vomiting  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Wound secretion  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Investigations     
Transaminases increased  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Haematocrit decreased  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Haemoglobin decreased  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Oxygen saturation decreased  1  1/50 (2.00%)  1 3/52 (5.77%)  3
Urin output decreased  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Alanine aminotransferase increased  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Aspartate aminotransferase increased  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Bacterial test positive  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Blood bilirubin increased  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Blood potassium decreased  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Platelet count decreased  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Platelet count increased  1  0/50 (0.00%)  0 3/52 (5.77%)  3
White blood cell count increased  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Mean arterial pressure decreased  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Protein total decreased  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Blood creatinin decreased  1  0/50 (0.00%)  0 1/52 (1.92%)  2
Activated partial thromboplastin time prolonged  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Blood albumin decreased  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Blood alkalyne phosphatase increased  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Blood glucose decreased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Blood magnesium decreased  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Blood phosphorus decreased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Blood zinc decreased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
C-reactive protein increased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Catheter culture positive  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Electrocardiogram QT prolonged  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Fibrin degradation products increased  1  0/50 (0.00%)  0 1/52 (1.92%)  1
International normalized ratio increased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Portal vein pressure increased  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Weight decreased  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1  22/50 (44.00%)  23 19/52 (36.54%)  22
Hypomagnesaemia  1  11/50 (22.00%)  11 14/52 (26.92%)  14
Hypoglycaemia  1  10/50 (20.00%)  12 11/52 (21.15%)  12
Hypophosphataemia  1  9/50 (18.00%)  9 12/52 (23.08%)  12
Hypoalbuminaemia  1  7/50 (14.00%)  7 6/52 (11.54%)  6
Hypernatraemia  1  6/50 (12.00%)  6 4/52 (7.69%)  4
Hypocalcaemia  1  4/50 (8.00%)  4 3/52 (5.77%)  3
Hypoinsulinaemia  1  2/50 (4.00%)  2 3/52 (5.77%)  3
Malnutrition  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Fluid retention  1  0/50 (0.00%)  0 4/52 (7.69%)  4
Hyperglycaemia  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Hypermagnesaemia  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Hypervolaemia  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Hypovolaemia  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Vitamin C deficiency  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Calcium deficiency  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Hypercalaemia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Vitamin A deficiency  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Fluid overload  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle spasms  1  1/50 (2.00%)  1 7/52 (13.46%)  8
Back pain  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Musculoskeletal pain  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Arthritis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Bursitis  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Intervertebral disk degeneration  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Muscular wickness  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Musculoskeletal chest pain  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Myofascial pain syndrome  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Nervous system disorders     
ìHeadache  1  0/50 (0.00%)  0 3/52 (5.77%)  3
Balance disorder  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Dizziness  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Hypoaesthesia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Neuropathy peripheral  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Paraesthesia  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Somnolence  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Stupor  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Unresponsive to stimuli  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Psychiatric disorders     
Anxiety  1  4/50 (8.00%)  4 11/52 (21.15%)  11
Insomnia  1  2/50 (4.00%)  2 3/52 (5.77%)  3
Confusional state  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Delirium  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Depression  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Hallucination  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Mental disorder  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Suicidal ideation  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Dyisuria  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Urinary retention  1  0/50 (0.00%)  0 2/52 (3.85%)  2
Bladder pain  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Bladder spasm  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Haematuria  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  3/50 (6.00%)  3 4/52 (7.69%)  4
Pleural effusion  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Pulmonary oedema  1  2/50 (4.00%)  2 2/52 (3.85%)  2
Asthma  1  2/50 (4.00%)  2 1/52 (1.92%)  1
Dyspnoea  1  1/50 (2.00%)  1 2/52 (3.85%)  2
Respiratory failure  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Atelectasis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Cough  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Nasal congestion  1  2/50 (4.00%)  2 0/52 (0.00%)  0
Apnoea  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Dysphonia  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Pulmonary thrombosis  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Respiratory depression  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Respiratory distress  1  1/50 (2.00%)  1 0/52 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  7/50 (14.00%)  7 6/52 (11.54%)  6
Hyperhidrosis  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Rush  1  1/50 (2.00%)  1 1/52 (1.92%)  1
Urticaria  1  0/50 (0.00%)  0 1/52 (1.92%)  1
Vascular disorders     
Hypotension  1  10/50 (20.00%)  10 12/52 (23.08%)  13
Hypertension  1  7/50 (14.00%)  9 4/52 (7.69%)  4
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mauro P. Ferrari, Pharm D
Organization: Dompé
Phone: +3902583831
EMail: info@dompe.com
Layout table for additonal information
Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT01967888    
Other Study ID Numbers: REP0112
First Submitted: October 18, 2013
First Posted: October 23, 2013
Results First Submitted: September 15, 2019
Results First Posted: October 9, 2019
Last Update Posted: July 23, 2020