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Clinical Trial in Patients Diagnosed With Immune Thrombocytopenic Purpura (ITP)

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: NCT00699140
Recruitment Status : Completed
First Posted : June 17, 2008
Results First Posted : February 8, 2016
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Immune (Idiopathic) Thrombocytopenic Purpura
Intervention Biological: IGIV3I Grifols
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses

Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  88.9%
>=65 years
2
  11.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
43
(20 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
12
  66.7%
Male
6
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Russian Federation 12
United Kingdom 2
Spain 4
Subjects with medical history of splenectomy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Yes 9
No 9
Subjects with haemorrhagic history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Yes 13
No 5
Platelet count  
Median (Full Range)
Unit of measure:  Platelets x 10^-9/L
Number Analyzed 18 participants
8.5
(3.0 to 36.0)
1.Primary Outcome
Title Responder Patients
Hide Description The primary efficacy endpoint was the proportion of patients who reached a platelet count ≥ 50x10^9/L.
Time Frame At any time during the study period (The platelet count was measured at Days 1-6, 10, 14. 21, 30, 60, 90).
Hide Outcome Measure Data
Hide Analysis Population Description
All 18 subjects received at least one infusion (at any dose) of IGIV3I Grifols and were included in the intent-to-treat (ITT) population for efficacy and safety analysis.
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
72.2
(50.2 to 88.4)
2.Secondary Outcome
Title Maximum Platelet Level Reached During the Follow-up Period
Hide Description Platelet count was measured at various time points in the follow-up period after infusion.
Time Frame During the follow-up period (time points: Days 6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Hide Outcome Measure Data
Hide Analysis Population Description
The maximum platelet counts were taken from the population who responded to treatment (platelet count ≥ 50x10^9/L). If any patient received banned medication due to ITP progression during the study, the values obtained after patients received treatment were excluded.
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: platelets x 10^-9/L
146.0
(71.0 to 763.0)
3.Secondary Outcome
Title Time to Reach Platelet Count ≥ 50x10^9/L (≤ Days)
Hide Description The time taken for the platelet count to reach ≥ 50x10^9/L from first dose
Time Frame At any time during the study period (time points: Days 1-6, 10, 14, 21, 30, 60, 90 post-first infusion day [Day 1])
Hide Outcome Measure Data
Hide Analysis Population Description
From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population but only 13 responded to the treatment
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: days
2
(0 to 5)
4.Secondary Outcome
Title Length of Time Platelet Count Remains ≥ 50x10^9/L (≥ Days)
Hide Description Length of time platelet count remained ≥ 50x10^9/L from first dose (Day 1)
Time Frame At any time during the study period (up to 3 months [90 days])
Hide Outcome Measure Data
Hide Analysis Population Description
From all 18 subjects who received at least one infusion and were included in the intent-to-treat (ITT) population only 13 responded to the treatment
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: days
9
(3 to 61)
5.Secondary Outcome
Title Regression of Hemorrhages.
Hide Description

Percentage of subjects with regression of hemorrhages of Types 1 to 3:

  • Type 0: Patients without symptoms of bleeding at the first infusion continue without presenting spontaneous bleeding
  • Type 1: Patients with bleeding symptoms at the first infusion had a reduction of the size of large ecchymoses, and no spontaneous appearance of new ecchymoses
  • Type 2: Patients with bleeding symptoms at the first infusion had a decrease in the number of cutaneous petechiae, or the extent of the affected area of the body decreased
  • Type 3: Patients had active mucosal bleedings at the first infusion, these episodes stopped without re-bleeding, and there was no occurrence of new spontaneous mucosal hemorrhages (e.g., gingival bleeding, epistaxis)
Time Frame First 10 to14 days since the first infusion day (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: patients who received at least one infusion of the study drug
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
83.3
(62.3 to 95.3)
6.Secondary Outcome
Title Frequency of Adverse Reactions During and After Infusions by Percentage of Patients
Hide Description All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of patients with at least one AE and adverse drug reactions are estimated.
Time Frame At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: patient who received one infusion with the study drug.
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols. IGIV3I Grifols: Immune Globulin Intravenous (Human). All adverse events (AEs) are tabulated and summarized. Incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of MedDRA.

The frequency of patients and infusions associated with at least one AE are estimated as the primary safety endpoint.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of patients
Frequency of patients with AEs 88.9
Frequency of patients with adverse drug reactions 38.9
7.Secondary Outcome
Title Frequency of Adverse Reactions During and After Infusions by Percentage of Infusions
Hide Description All adverse events (AEs) are tabulated and summarized. The incidence, severity, and causal relationship of the AEs to IGIV3I Grifols are presented by system organ class after medical coding according to the version 15.0 of Medical Dictionary for Regulatory Activities (MedDRA). The frequency of infusions associated with at least one AE and adverse drug reactions are estimated.
Time Frame At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: patient who received at least one infusion with the study drug.
Arm/Group Title 1 Treatment Group With IGIV3I Grifols
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of infusions
Frequency of infusions with adverse events 26.3
Frequency of infusions with adverse drug reactions 24.6
8.Secondary Outcome
Title Changes in Vital Signs and Clinically Relevant Changes in Laboratory Parameters After the Infusions, Including Renal Function (Creatinine Levels)
Hide Description Laboratory parameters at each treatment day and visit are summarized by patient. Results were marked as normal/abnormal (whether the result is below, within or above the respective reference range) and relevant/irrelevant (as determined by the investigator). The number of abnormal values considered clinically relevant changes (based on the investigator's judgment) was listed.
Time Frame At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title 1 Treatment Group With IGIV3I Grifols
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses.

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Clinically relevant changes in vital signs 0
Clinically relevant changes in lab parameters 7
9.Secondary Outcome
Title Viral Safety Through the Investigation of Patients Virology Status (Hepatitis A Virus [HA
Hide Description The results of HIV-1 and -2 antibodies, HCV antibody, HBsAg, HBV antibodies, HAV antibodies, HIV nucleic acid amplification test [NAT], and HCV NAT on Day 1, Day 14, and at Month 1, Month 2 and Month 3 were recorded for several of these markers (as appropriate). A comparison of negative viral markers on Day 1 and Month 3 was performed
Time Frame At any time during the study period (from patient's signature of the informed consent form until 3 months of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title 1 Treatment Group With IGIV3I
Hide Arm/Group Description:

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

Each patient received a total dose of 2 g/kg IGIV3I Grifols, given intravenously over either 2 days or 5 days in divided doses

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: seroconversions
0
Time Frame 3 months
Adverse Event Reporting Description At any time during the study period (from patient´s signature of the informed consent until 3 months of follow-up)
 
Arm/Group Title 1 Treatment Group With IGIV3I Grifols
Hide Arm/Group Description

Open label, non-randomized treatment group with IGIV3I Grifols

IGIV3I Grifols: Immune Globulin Intravenous (Human)

All-Cause Mortality
1 Treatment Group With IGIV3I Grifols
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
1 Treatment Group With IGIV3I Grifols
Affected / at Risk (%) # Events
Total   2/18 (11.11%)    
Blood and lymphatic system disorders   
Leukopenia  1 [1]  1/18 (5.56%)  1
Investigations   
Haemoglobin decreased  1 [2]  1/18 (5.56%)  1
Vascular disorders   
Thrombosis  1 [3]  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
A 75-year-old male with high blood glucose levels and hypertension presented a drop in leukocyte count from 5.3x10^9/L to 2.7x10^9/L. The reaction was transient, with no complications. The subject was discharged from hospital totally recovered
[2]
A 75-year-old male with high blood glucose levels and hypertension presented a drop in hemoglobin from 11.7 g/dL to 9.8 g/dL. The reaction was transient with no complications or clinical symptoms of hemolysis. The subject was recovered from the event
[3]
A male subject of 54-year-old, with morbid obesity, sedentary lifestyle, previous steroid treatment and difficulty with line insertion was diagnosed with deep venous thrombosis and hospitalized. The subject recovered from the event.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 Treatment Group With IGIV3I Grifols
Affected / at Risk (%) # Events
Total   12/18 (66.67%)    
Blood and lymphatic system disorders   
Bicytopenia  1 [1]  1/18 (5.56%)  1
Gastrointestinal disorders   
Abdominal distension  1 [2]  1/18 (5.56%)  3
Gingival bleeding  1 [3]  2/18 (11.11%)  2
Haemorrhoidal haemorrhage  1 [4]  1/18 (5.56%)  2
Nausea  1 [1]  1/18 (5.56%)  1
Vomiting  1 [5]  1/18 (5.56%)  1
General disorders   
Pyrexia  1 [6]  4/18 (22.22%)  4
Chills  1 [7]  2/18 (11.11%)  2
Fatigue  1 [8]  1/18 (5.56%)  2
Immune system disorders   
Drug hypersensitivity  1 [1]  1/18 (5.56%)  1
Infections and infestations   
Nasopharyngitis  1 [4]  1/18 (5.56%)  2
Investigations   
Alanine aminotransferase increased  1 [9]  1/18 (5.56%)  1
Blood cholesterol increased  1 [9]  1/18 (5.56%)  1
Blood triglycerides increased  1 [9]  1/18 (5.56%)  1
Lipids abnormal  1 [9]  1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders   
Limb discomfort  1 [10]  1/18 (5.56%)  2
Myalgia  1 [11]  1/18 (5.56%)  1
Nervous system disorders   
Headache  1 [12]  7/18 (38.89%)  15
Radicular syndrome  1 [1]  1/18 (5.56%)  1
Renal and urinary disorders   
Haematuria  1 [9]  1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1 [4]  1/18 (5.56%)  2
Epistaxis  1 [9]  1/18 (5.56%)  1
Rhinorrhoea  1 [11]  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Petechiae  1 [13]  12/18 (66.67%)  15
Ecchymosis  1 [14]  8/18 (44.44%)  11
Palmar erythema  1 [1]  1/18 (5.56%)  1
Rash  1 [15]  2/18 (11.11%)  2
Vascular disorders   
Haematoma  1 [9]  1/18 (5.56%)  1
Hypertension  1 [16]  2/18 (11.11%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
[1]
It was considered related to the study drug
[2]
One patient had 3 events that were considered not related to the study drug
[3]
Two patients had 2 events that were considered not related to the study drug
[4]
A patient had 2 events that were considered not related to the study drug
[5]
It was considered related to the stuy drug
[6]
Three out of 4 events were considered related to the study drug
[7]
All of 2 events were considered related to the study drug
[8]
Two events were considered related to the study drug
[9]
It was considered not related to the study drug
[10]
A patient had 2 events that were considered related to the study drug
[11]
A patient had 1 event that was considered not related to the study drug
[12]
Twelve out of 15 events were considered related to the study drug
[13]
All of these events were considered not related to the study drug
[14]
Only 1 out of 11 events was considered related to the study drug
[15]
Only 1 of the 2 events was considered related to the study drug
[16]
Two patients had 3 events that were considered related to the study drug
The patient number was based on European Medicines Agency guidance to evaluate IVIG products in ITP patients (EMEA/CPMP/BPWG/388/95 rev.1, June 2000, in force when the study was designed): at least 15 subjects were sufficient for the analysis.
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: Marta Carretero, PhD, Clinical Project Leader
Organization: Instituto Grifols, S.A
Phone: + 34 93 571 22 00
EMail: marta.carretero@grifols.com
Layout table for additonal information
Responsible Party: Grifols Biologicals, LLC ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00699140    
Other Study ID Numbers: IG202
First Submitted: June 16, 2008
First Posted: June 17, 2008
Results First Submitted: June 16, 2015
Results First Posted: February 8, 2016
Last Update Posted: February 8, 2016