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Trial record 2 of 92 for:    Primary Sclerosing Cholangitis

PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT02653625
Recruitment Status : Completed
First Posted : January 12, 2016
Results First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis
Intervention Drug: Cenicriviroc 150 mg
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Period Title: Overall Study
Started 24
Completed 20
Not Completed 4
Reason Not Completed
Adverse Event             1
Non-compliance with Study Drug             1
Protocol Violation             1
Suspected Drug Induced Liver Injury             1
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) and Safety Analysis Sets: All enrolled participants who received at least 1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
43.3  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
12
  50.0%
Male
12
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
White
21
  87.5%
Black or African American
1
   4.2%
Asian
1
   4.2%
Other
1
   4.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic
2
   8.3%
Not Hispanic
22
  91.7%
1.Primary Outcome
Title Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP)
Hide Description ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The percent change from Baseline was defined as 100*(value at each visit - Baseline value)/Baseline value. The Baseline value was defined as the last non-missing value on or before the Baseline visit (Day 1). A negative percentage change from baseline indicates an improvement.
Time Frame Baseline (Day 1) to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percentage change in ALP
-4.5  (34.84)
2.Secondary Outcome
Title Percentage of Participants Who Normalized ALP at Week 24
Hide Description ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. Normalization was defined as ALP values outside of the central laboratory reference range at baseline, but within the central laboratory reference range at Week 24.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
0.0
3.Secondary Outcome
Title Percentage of Participants Who Achieved Serum ALP of Less Than 1.5 Times Upper Limit of Normal (ULN) in Serum ALP at Week 24
Hide Description ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The upper limit of normal ALP was defined according to the central laboratory reference ranges.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
10
4.Secondary Outcome
Title Percentage of Participants Who Achieved a 50% Decrease in ALP at Week 24
Hide Description ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
0.0
5.Secondary Outcome
Title Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
Time Frame Baseline (Day 1) to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of participants
83.3
6.Secondary Outcome
Title Percentage of Participants Who Discontinued Due to a TEAE
Hide Description An adverse event was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.
Time Frame Baseline (Day 1) to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description:
Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of participants
8.3
Time Frame From Baseline (Day 1) to Week 24
Adverse Event Reporting Description Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.
 
Arm/Group Title Cenicriviroc 150 mg
Hide Arm/Group Description Cenicriviroc 150 mg was administered orally once daily with food in the morning for 24 weeks.
All-Cause Mortality
Cenicriviroc 150 mg
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cenicriviroc 150 mg
Affected / at Risk (%)
Total   1/24 (4.17%) 
Hepatobiliary disorders   
Gallbladder polyp  1  1/24 (4.17%) 
1
Term from vocabulary, MedDRA, Version 16.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cenicriviroc 150 mg
Affected / at Risk (%)
Total   20/24 (83.33%) 
Gastrointestinal disorders   
Vomiting  1  3/24 (12.50%) 
Nausea  1  2/24 (8.33%) 
General disorders   
Fatigue  1  4/24 (16.67%) 
Pyrexia  1  2/24 (8.33%) 
Infections and infestations   
Lower respiratory tract infection  1  2/24 (8.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/24 (8.33%) 
Musculoskeletal chest pain  1  2/24 (8.33%) 
Nervous system disorders   
Dizziness  1  4/24 (16.67%) 
Headache  1  3/24 (12.50%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/24 (12.50%) 
Skin and subcutaneous tissue disorders   
Rash  1  4/24 (16.67%) 
Pruritus  1  2/24 (8.33%) 
Rash pruritic  1  2/24 (8.33%) 
1
Term from vocabulary, MedDRA, Version 16.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02653625     History of Changes
Other Study ID Numbers: 652-205
First Submitted: January 8, 2016
First Posted: January 12, 2016
Results First Submitted: August 31, 2018
Results First Posted: October 1, 2018
Last Update Posted: October 1, 2018