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AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH) (AURORA)

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: NCT03028740
Recruitment Status : Terminated (This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.)
First Posted : January 23, 2017
Results First Posted : March 10, 2022
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis
Interventions Drug: Placebo
Drug: Cenicriviroc
Enrollment 1778
Recruitment Details  
Pre-assignment Details 1778 participants were randomized into the study, of which 1293 participated in Part 1 of the study. The study was terminated early, and Part 2 did not enroll the planned number of participants. Therefore, the Part 1 and Part 2 data were combined and reported as the Full Study Cohort for reporting of the Part 2 efficacy endpoints and the safety endpoints.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Period Title: Overall Study
Started 593 1185
Full Study Cohort: Received Study Drug 589 1180
Participated in Part 1 432 861
Part 1: Received Study Drug 429 859
Completed 0 0
Not Completed 593 1185
Reason Not Completed
Did not Receive Study Drug             4             5
Adverse Event             8             26
Lack of Efficacy             0             1
Withdrawal by Subject             48             101
Lost to Follow-up             30             54
Physician Decision             4             11
Protocol Violation             4             8
Non-compliance with Study Drug             0             2
Study Terminated by Sponsor             467             917
Protocol-specified Withdrawal Criteria Met             27             55
Reason not Specified             1             5
Arm/Group Title Placebo Cenicriviroc 150 mg Total
Hide Arm/Group Description Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months. Total of all reporting groups
Overall Number of Baseline Participants 589 1180 1769
Hide Baseline Analysis Population Description
Modified Intent-to-Treat (mITT) Population for the Full Study Cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 589 participants 1180 participants 1769 participants
55.8  (11.04) 55.2  (10.76) 55.4  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 589 participants 1180 participants 1769 participants
Female
354
  60.1%
749
  63.5%
1103
  62.4%
Male
235
  39.9%
431
  36.5%
666
  37.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 589 participants 1180 participants 1769 participants
Hispanic or Latino
172
  29.2%
315
  26.7%
487
  27.5%
Not Hispanic or Latino
417
  70.8%
865
  73.3%
1282
  72.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 589 participants 1180 participants 1769 participants
American Indian or Alaska Native
7
   1.2%
8
   0.7%
15
   0.8%
Asian
22
   3.7%
45
   3.8%
67
   3.8%
Native Hawaiian or Other Pacific Islander
2
   0.3%
7
   0.6%
9
   0.5%
Black or African American
14
   2.4%
38
   3.2%
52
   2.9%
White
539
  91.5%
1075
  91.1%
1614
  91.2%
More than one race
3
   0.5%
6
   0.5%
9
   0.5%
Unknown or Not Reported
2
   0.3%
1
   0.1%
3
   0.2%
1.Primary Outcome
Title Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12
Hide Description Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 429 859
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.5
(21.5 to 29.9)
22.3
(19.6 to 25.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2067
Comments P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-8.2 to 1.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8369
Confidence Interval (2-Sided) 95%
0.6341 to 1.1044
Estimation Comments Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).
2.Primary Outcome
Title Time to First Occurrence of Adjudicated Events in the Full Study Cohort
Hide Description Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.
Time Frame From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 589 1180
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Median, lower and upper limit of 95% confidence interval (C.I.) were not estimable due to low number of participants with events.
[2]
Median, lower and upper limit of 95% C.I. were not estimable due to low number of participants with events.
3.Secondary Outcome
Title Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 429 859
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(6.0 to 11.3)
6.6
(5.1 to 8.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2827
Comments P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-4.8 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.7844
Confidence Interval (2-Sided) 95%
0.5032 to 1.2229
Estimation Comments Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).
4.Secondary Outcome
Title Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 348 692
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(28.6 to 38.4)
30.6
(27.3 to 34.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4054
Comments P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-8.7 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Cenicriviroc 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.8877
Confidence Interval (2-Sided) 95%
0.6709 to 1.1744
Estimation Comments Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage [2 vs 3] and presence or absence of T2DM at Baseline).
5.Secondary Outcome
Title Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for Part 1 included participants randomly assigned to a treatment group who received at least one dose of study drug in Part 1. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 348 692
Measure Type: Number
Unit of Measure: percentage of participants
10.3 8.8
6.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 589 1180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(21.2 to 29.2)
22.0
(19.4 to 24.8)
7.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Drug: Placebo Drug: Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 373 741
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.2
(28.7 to 38.2)
30.5
(27.3 to 33.9)
8.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug for Parts 1 and 2 of the study combined.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 589 1180
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(5.9 to 11.1)
6.8
(5.2 to 8.6)
9.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population for the full study cohort included participants randomly assigned to a treatment group who received at least one dose of study drug in Parts 1 and 2 of the study combined. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 373 741
Measure Type: Number
Unit of Measure: percentage of participants
9.9 8.9
10.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected as the study was terminated and no participants reached the Month 60 timepoint.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected as the study was terminated and no participants reached the Month 60 timepoint.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected as the study was terminated and no participants reached the Month 60 timepoint.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Hide Description Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
No data was collected as the study was terminated and no participants reached the Month 60 timepoint.
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description:
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From first dose through 30 days after the last dose of study drug (Up to approximately 42 months)
Adverse Event Reporting Description All-cause Mortality: All enrolled participants. Serious Adverse Events and Other Adverse Events: Safety Population for the full study cohort included participants who received at least one dose of study drug in Parts 1 and 2 of the study combined.
 
Arm/Group Title Placebo Cenicriviroc 150 mg
Hide Arm/Group Description Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. Participants received cenicriviroc,150 mg, tablet, orally, once daily for up to approximately 40 months.
All-Cause Mortality
Placebo Cenicriviroc 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/593 (0.34%)   6/1185 (0.51%) 
Hide Serious Adverse Events
Placebo Cenicriviroc 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   70/589 (11.88%)   159/1180 (13.47%) 
Blood and lymphatic system disorders     
Blood loss anaemia  1  2/589 (0.34%)  1/1180 (0.08%) 
Anaemia  1  0/589 (0.00%)  1/1180 (0.08%) 
Immune thrombocytopenia  1  0/589 (0.00%)  1/1180 (0.08%) 
Lymphadenitis  1  0/589 (0.00%)  1/1180 (0.08%) 
Lymphadenopathy  1  0/589 (0.00%)  1/1180 (0.08%) 
Thrombocytopenia  1  0/589 (0.00%)  1/1180 (0.08%) 
Splenomegaly  1  1/589 (0.17%)  0/1180 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  2/589 (0.34%)  4/1180 (0.34%) 
Coronary artery disease  1  0/589 (0.00%)  4/1180 (0.34%) 
Angina pectoris  1  0/589 (0.00%)  3/1180 (0.25%) 
Atrial fibrillation  1  0/589 (0.00%)  3/1180 (0.25%) 
Myocardial infarction  1  1/589 (0.17%)  2/1180 (0.17%) 
Acute coronary syndrome  1  0/589 (0.00%)  2/1180 (0.17%) 
Aortic valve incompetence  1  0/589 (0.00%)  2/1180 (0.17%) 
Aortic valve disease  1  0/589 (0.00%)  1/1180 (0.08%) 
Aortic valve disease mixed  1  0/589 (0.00%)  1/1180 (0.08%) 
Cardiac failure  1  0/589 (0.00%)  1/1180 (0.08%) 
Cardiac failure congestive  1  0/589 (0.00%)  1/1180 (0.08%) 
Left ventricular hypertrophy  1  0/589 (0.00%)  1/1180 (0.08%) 
Mitral valve incompetence  1  0/589 (0.00%)  1/1180 (0.08%) 
Palpitations  1  0/589 (0.00%)  1/1180 (0.08%) 
Pulseless electrical activity  1  0/589 (0.00%)  1/1180 (0.08%) 
Stress cardiomyopathy  1  0/589 (0.00%)  1/1180 (0.08%) 
Angina unstable  1  1/589 (0.17%)  0/1180 (0.00%) 
Cardiac arrest  1  1/589 (0.17%)  0/1180 (0.00%) 
Coronary artery stenosis  1  1/589 (0.17%)  0/1180 (0.00%) 
Congenital, familial and genetic disorders     
Phimosis  1 [1]  0/235 (0.00%)  1/431 (0.23%) 
Ear and labyrinth disorders     
Vertigo  1  1/589 (0.17%)  4/1180 (0.34%) 
Vertigo positional  1  1/589 (0.17%)  0/1180 (0.00%) 
Endocrine disorders     
Hypoparathyroidism  1  1/589 (0.17%)  0/1180 (0.00%) 
Hypothyroidism  1  1/589 (0.17%)  0/1180 (0.00%) 
Thyroid mass  1  1/589 (0.17%)  0/1180 (0.00%) 
Eye disorders     
Visual impairment  1  0/589 (0.00%)  1/1180 (0.08%) 
Gastrointestinal disorders     
Pancreatitis acute  1  2/589 (0.34%)  6/1180 (0.51%) 
Colitis  1  1/589 (0.17%)  2/1180 (0.17%) 
Small intestinal obstruction  1  0/589 (0.00%)  2/1180 (0.17%) 
Abdominal pain  1  2/589 (0.34%)  1/1180 (0.08%) 
Diverticular perforation  1  0/589 (0.00%)  1/1180 (0.08%) 
Rectal haemorrhage  1  0/589 (0.00%)  1/1180 (0.08%) 
Vomiting  1  0/589 (0.00%)  1/1180 (0.08%) 
Abdominal distension  1  1/589 (0.17%)  0/1180 (0.00%) 
Abdominal hernia  1  1/589 (0.17%)  0/1180 (0.00%) 
Abdominal pain lower  1  1/589 (0.17%)  0/1180 (0.00%) 
Alcoholic pancreatitis  1  1/589 (0.17%)  0/1180 (0.00%) 
Hiatus hernia  1  1/589 (0.17%)  0/1180 (0.00%) 
Impaired gastric emptying  1  1/589 (0.17%)  0/1180 (0.00%) 
Mesenteric panniculitis  1  1/589 (0.17%)  0/1180 (0.00%) 
General disorders     
Non-cardiac chest pain  1  2/589 (0.34%)  4/1180 (0.34%) 
Fatigue  1  0/589 (0.00%)  2/1180 (0.17%) 
Chest pain  1  1/589 (0.17%)  1/1180 (0.08%) 
Death  1  0/589 (0.00%)  1/1180 (0.08%) 
Generalised oedema  1  0/589 (0.00%)  1/1180 (0.08%) 
Pyrexia  1  0/589 (0.00%)  1/1180 (0.08%) 
Systemic inflammatory response syndrome  1  0/589 (0.00%)  1/1180 (0.08%) 
Malaise  1  1/589 (0.17%)  0/1180 (0.00%) 
Hepatobiliary disorders     
Autoimmune hepatitis  1  0/589 (0.00%)  1/1180 (0.08%) 
Cholecystitis acute  1  0/589 (0.00%)  1/1180 (0.08%) 
Cholelithiasis  1  0/589 (0.00%)  1/1180 (0.08%) 
Cholecystitis  1  2/589 (0.34%)  0/1180 (0.00%) 
Hepatic cirrhosis  1  1/589 (0.17%)  0/1180 (0.00%) 
Non-alcoholic steatohepatitis  1  1/589 (0.17%)  0/1180 (0.00%) 
Infections and infestations     
COVID-19 pneumonia  1  2/589 (0.34%)  6/1180 (0.51%) 
Pneumonia  1  4/589 (0.68%)  5/1180 (0.42%) 
COVID-19  1  2/589 (0.34%)  5/1180 (0.42%) 
Cellulitis  1  2/589 (0.34%)  4/1180 (0.34%) 
Sepsis  1  5/589 (0.85%)  2/1180 (0.17%) 
Diverticulitis  1  2/589 (0.34%)  2/1180 (0.17%) 
Gastroenteritis  1  2/589 (0.34%)  1/1180 (0.08%) 
Pyelonephritis  1  2/589 (0.34%)  1/1180 (0.08%) 
Osteomyelitis  1  1/589 (0.17%)  1/1180 (0.08%) 
Acute sinusitis  1  0/589 (0.00%)  1/1180 (0.08%) 
Appendicitis  1  0/589 (0.00%)  1/1180 (0.08%) 
Gallbladder empyema  1  0/589 (0.00%)  1/1180 (0.08%) 
Gangrene  1  0/589 (0.00%)  1/1180 (0.08%) 
Influenza  1  0/589 (0.00%)  1/1180 (0.08%) 
Kidney infection  1  0/589 (0.00%)  1/1180 (0.08%) 
Post procedural infection  1  0/589 (0.00%)  1/1180 (0.08%) 
Postoperative abscess  1  0/589 (0.00%)  1/1180 (0.08%) 
Pulmonary sepsis  1  0/589 (0.00%)  1/1180 (0.08%) 
Pyelonephritis acute  1  0/589 (0.00%)  1/1180 (0.08%) 
Rhinovirus infection  1  0/589 (0.00%)  1/1180 (0.08%) 
Sinusitis  1  0/589 (0.00%)  1/1180 (0.08%) 
Streptococcal sepsis  1  0/589 (0.00%)  1/1180 (0.08%) 
Tooth abscess  1  0/589 (0.00%)  1/1180 (0.08%) 
Bronchitis  1  2/589 (0.34%)  0/1180 (0.00%) 
Abdominal infection  1  1/589 (0.17%)  0/1180 (0.00%) 
Atypical pneumonia  1  1/589 (0.17%)  0/1180 (0.00%) 
Cholecystitis infective  1  1/589 (0.17%)  0/1180 (0.00%) 
Empyema  1  1/589 (0.17%)  0/1180 (0.00%) 
Herpes zoster oticus  1  1/589 (0.17%)  0/1180 (0.00%) 
Perineal abscess  1  1/589 (0.17%)  0/1180 (0.00%) 
Vulval cellulitis  1 [2]  1/354 (0.28%)  0/749 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  5/589 (0.85%)  2/1180 (0.17%) 
Post procedural haematoma  1  2/589 (0.34%)  2/1180 (0.17%) 
Procedural pain  1  1/589 (0.17%)  2/1180 (0.17%) 
Tibia fracture  1  1/589 (0.17%)  2/1180 (0.17%) 
Multiple injuries  1  0/589 (0.00%)  2/1180 (0.17%) 
Road traffic accident  1  1/589 (0.17%)  1/1180 (0.08%) 
Animal bite  1  0/589 (0.00%)  1/1180 (0.08%) 
Craniocerebral injury  1  0/589 (0.00%)  1/1180 (0.08%) 
Fibula fracture  1  0/589 (0.00%)  1/1180 (0.08%) 
Humerus fracture  1  0/589 (0.00%)  1/1180 (0.08%) 
Limb injury  1  0/589 (0.00%)  1/1180 (0.08%) 
Post procedural contusion  1  0/589 (0.00%)  1/1180 (0.08%) 
Post procedural hypotension  1  0/589 (0.00%)  1/1180 (0.08%) 
Tendon rupture  1  0/589 (0.00%)  1/1180 (0.08%) 
Thoracic vertebral fracture  1  0/589 (0.00%)  1/1180 (0.08%) 
Wrist fracture  1  0/589 (0.00%)  1/1180 (0.08%) 
Ankle fracture  1  3/589 (0.51%)  0/1180 (0.00%) 
Femur fracture  1  2/589 (0.34%)  0/1180 (0.00%) 
Anaemia postoperative  1  1/589 (0.17%)  0/1180 (0.00%) 
Femoral neck fracture  1  1/589 (0.17%)  0/1180 (0.00%) 
Post procedural complication  1  1/589 (0.17%)  0/1180 (0.00%) 
Post procedural discomfort  1  1/589 (0.17%)  0/1180 (0.00%) 
Rib fracture  1  1/589 (0.17%)  0/1180 (0.00%) 
Snake bite  1  1/589 (0.17%)  0/1180 (0.00%) 
Investigations     
SARS-CoV-2 test positive  1  0/589 (0.00%)  1/1180 (0.08%) 
Serum ferritin increased  1  0/589 (0.00%)  1/1180 (0.08%) 
Blood uric acid increased  1  1/589 (0.17%)  0/1180 (0.00%) 
Transaminases increased  1  1/589 (0.17%)  0/1180 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  0/589 (0.00%)  2/1180 (0.17%) 
Alkalosis hypochloraemic  1  0/589 (0.00%)  1/1180 (0.08%) 
Alkalosis hypokalaemic  1  0/589 (0.00%)  1/1180 (0.08%) 
Diabetic ketoacidosis  1  0/589 (0.00%)  1/1180 (0.08%) 
Hyperkalaemia  1  0/589 (0.00%)  1/1180 (0.08%) 
Hypoglycaemia  1  0/589 (0.00%)  1/1180 (0.08%) 
Hypomagnesaemia  1  0/589 (0.00%)  1/1180 (0.08%) 
Type 2 diabetes mellitus  1  0/589 (0.00%)  1/1180 (0.08%) 
Dehydration  1  1/589 (0.17%)  0/1180 (0.00%) 
Diabetes mellitus inadequate control  1  1/589 (0.17%)  0/1180 (0.00%) 
Hypercalcaemia  1  1/589 (0.17%)  0/1180 (0.00%) 
Hyperglycaemia  1  1/589 (0.17%)  0/1180 (0.00%) 
Hypocalcaemia  1  1/589 (0.17%)  0/1180 (0.00%) 
Hypokalaemia  1  1/589 (0.17%)  0/1180 (0.00%) 
Obesity  1  1/589 (0.17%)  0/1180 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/589 (0.00%)  4/1180 (0.34%) 
Intervertebral disc degeneration  1  0/589 (0.00%)  2/1180 (0.17%) 
Facet joint syndrome  1  0/589 (0.00%)  1/1180 (0.08%) 
Flank pain  1  0/589 (0.00%)  1/1180 (0.08%) 
Intervertebral disc displacement  1  0/589 (0.00%)  1/1180 (0.08%) 
Intervertebral disc protrusion  1  0/589 (0.00%)  1/1180 (0.08%) 
Lumbar spinal stenosis  1  0/589 (0.00%)  1/1180 (0.08%) 
Mixed connective tissue disease  1  0/589 (0.00%)  1/1180 (0.08%) 
Myositis  1  0/589 (0.00%)  1/1180 (0.08%) 
Osteoarthritis  1  0/589 (0.00%)  1/1180 (0.08%) 
Pain in extremity  1  0/589 (0.00%)  1/1180 (0.08%) 
Cervical spinal stenosis  1  2/589 (0.34%)  0/1180 (0.00%) 
Muscular weakness  1  2/589 (0.34%)  0/1180 (0.00%) 
Chest wall haematoma  1  1/589 (0.17%)  0/1180 (0.00%) 
Exostosis  1  1/589 (0.17%)  0/1180 (0.00%) 
Systemic lupus erythematosus  1  1/589 (0.17%)  0/1180 (0.00%) 
Tendonitis  1  1/589 (0.17%)  0/1180 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma of skin  1  0/589 (0.00%)  3/1180 (0.25%) 
Basal cell carcinoma  1  0/589 (0.00%)  2/1180 (0.17%) 
Prostate cancer  1 [1]  0/235 (0.00%)  2/431 (0.46%) 
Acoustic neuroma  1  0/589 (0.00%)  1/1180 (0.08%) 
Adenocarcinoma pancreas  1  0/589 (0.00%)  1/1180 (0.08%) 
Basosquamous carcinoma  1  0/589 (0.00%)  1/1180 (0.08%) 
Bile duct cancer  1  0/589 (0.00%)  1/1180 (0.08%) 
Bladder transitional cell carcinoma  1  0/589 (0.00%)  1/1180 (0.08%) 
Bowen's disease  1  0/589 (0.00%)  1/1180 (0.08%) 
Brain neoplasm benign  1  0/589 (0.00%)  1/1180 (0.08%) 
Endometrial neoplasm  1 [2]  0/354 (0.00%)  1/749 (0.13%) 
Hepatic cancer  1  0/589 (0.00%)  1/1180 (0.08%) 
Intraductal proliferative breast lesion  1  0/589 (0.00%)  1/1180 (0.08%) 
Invasive ductal breast carcinoma  1  0/589 (0.00%)  1/1180 (0.08%) 
Leiomyosarcoma  1  0/589 (0.00%)  1/1180 (0.08%) 
Malignant melanoma of eyelid  1  0/589 (0.00%)  1/1180 (0.08%) 
Non-small cell lung cancer  1  0/589 (0.00%)  1/1180 (0.08%) 
Pancreatic neuroendocrine tumour  1  0/589 (0.00%)  1/1180 (0.08%) 
Papillary thyroid cancer  1  0/589 (0.00%)  1/1180 (0.08%) 
Pituitary tumour benign  1  0/589 (0.00%)  1/1180 (0.08%) 
Plasma cell myeloma  1  0/589 (0.00%)  1/1180 (0.08%) 
Renal cancer  1  0/589 (0.00%)  1/1180 (0.08%) 
Squamous cell carcinoma  1  0/589 (0.00%)  1/1180 (0.08%) 
Hepatocellular carcinoma  1  2/589 (0.34%)  0/1180 (0.00%) 
Pancreatic carcinoma  1  2/589 (0.34%)  0/1180 (0.00%) 
Brain neoplasm  1  1/589 (0.17%)  0/1180 (0.00%) 
Endometrial cancer  1 [2]  1/354 (0.28%)  0/749 (0.00%) 
Malignant melanoma  1  1/589 (0.17%)  0/1180 (0.00%) 
Tumour of ampulla of Vater  1  1/589 (0.17%)  0/1180 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  2/589 (0.34%)  3/1180 (0.25%) 
Transient ischaemic attack  1  1/589 (0.17%)  3/1180 (0.25%) 
Paraesthesia  1  0/589 (0.00%)  2/1180 (0.17%) 
Dizziness  1  1/589 (0.17%)  1/1180 (0.08%) 
Loss of consciousness  1  1/589 (0.17%)  1/1180 (0.08%) 
Brain stem infarction  1  0/589 (0.00%)  1/1180 (0.08%) 
Cervical radiculopathy  1  0/589 (0.00%)  1/1180 (0.08%) 
Facial paralysis  1  0/589 (0.00%)  1/1180 (0.08%) 
Headache  1  0/589 (0.00%)  1/1180 (0.08%) 
Radial nerve palsy  1  0/589 (0.00%)  1/1180 (0.08%) 
Coma  1  1/589 (0.17%)  0/1180 (0.00%) 
Hypersomnia  1  1/589 (0.17%)  0/1180 (0.00%) 
Lethargy  1  1/589 (0.17%)  0/1180 (0.00%) 
Syncope  1  1/589 (0.17%)  0/1180 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ruptured ectopic pregnancy  1 [2]  1/354 (0.28%)  0/749 (0.00%) 
Product Issues     
Device dislocation  1  0/589 (0.00%)  1/1180 (0.08%) 
Psychiatric disorders     
Depression  1  1/589 (0.17%)  2/1180 (0.17%) 
Suicidal ideation  1  1/589 (0.17%)  1/1180 (0.08%) 
Mental status changes  1  1/589 (0.17%)  0/1180 (0.00%) 
Psychiatric decompensation  1  1/589 (0.17%)  0/1180 (0.00%) 
Suicide attempt  1  1/589 (0.17%)  0/1180 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  0/589 (0.00%)  4/1180 (0.34%) 
Acute kidney injury  1  1/589 (0.17%)  3/1180 (0.25%) 
Haematuria  1  0/589 (0.00%)  2/1180 (0.17%) 
Renal colic  1  0/589 (0.00%)  2/1180 (0.17%) 
Ureterolithiasis  1  0/589 (0.00%)  1/1180 (0.08%) 
Urinary retention  1  0/589 (0.00%)  1/1180 (0.08%) 
Urinary tract obstruction  1  0/589 (0.00%)  1/1180 (0.08%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1 [1]  1/235 (0.43%)  1/431 (0.23%) 
Metrorrhagia  1 [2]  0/354 (0.00%)  1/749 (0.13%) 
Polycystic ovaries  1 [2]  0/354 (0.00%)  1/749 (0.13%) 
Endometrial hyperplasia  1 [2]  1/354 (0.28%)  0/749 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/589 (0.00%)  3/1180 (0.25%) 
Asthma  1  0/589 (0.00%)  2/1180 (0.17%) 
Pleural effusion  1  1/589 (0.17%)  1/1180 (0.08%) 
Acute respiratory distress syndrome  1  0/589 (0.00%)  1/1180 (0.08%) 
Dyspnoea  1  0/589 (0.00%)  1/1180 (0.08%) 
Interstitial lung disease  1  0/589 (0.00%)  1/1180 (0.08%) 
Respiratory distress  1  0/589 (0.00%)  1/1180 (0.08%) 
Sleep apnoea syndrome  1  0/589 (0.00%)  1/1180 (0.08%) 
Acute respiratory failure  1  1/589 (0.17%)  0/1180 (0.00%) 
Chronic obstructive pulmonary disease  1  1/589 (0.17%)  0/1180 (0.00%) 
Haemothorax  1  1/589 (0.17%)  0/1180 (0.00%) 
Respiratory failure  1  1/589 (0.17%)  0/1180 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash erythematous  1  1/589 (0.17%)  1/1180 (0.08%) 
Diabetic foot  1  0/589 (0.00%)  1/1180 (0.08%) 
Pruritus  1  0/589 (0.00%)  1/1180 (0.08%) 
Vascular disorders     
Aortic stenosis  1  1/589 (0.17%)  1/1180 (0.08%) 
Deep vein thrombosis  1  0/589 (0.00%)  1/1180 (0.08%) 
Hypertension  1  0/589 (0.00%)  1/1180 (0.08%) 
Phlebolith  1  0/589 (0.00%)  1/1180 (0.08%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
[1]
Number of participants at risk in each arm is based on the male population.
[2]
Number of participants at risk in each arm is based on the female population.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Cenicriviroc 150 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   218/589 (37.01%)   425/1180 (36.02%) 
Gastrointestinal disorders     
Nausea  1  39/589 (6.62%)  104/1180 (8.81%) 
Diarrhoea  1  56/589 (9.51%)  92/1180 (7.80%) 
Abdominal pain upper  1  26/589 (4.41%)  64/1180 (5.42%) 
Abdominal pain  1  30/589 (5.09%)  56/1180 (4.75%) 
General disorders     
Fatigue  1  33/589 (5.60%)  74/1180 (6.27%) 
Infections and infestations     
Urinary tract infection  1  33/589 (5.60%)  57/1180 (4.83%) 
Upper respiratory tract infection  1  39/589 (6.62%)  41/1180 (3.47%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  35/589 (5.94%)  68/1180 (5.76%) 
Back pain  1  36/589 (6.11%)  54/1180 (4.58%) 
Nervous system disorders     
Headache  1  30/589 (5.09%)  64/1180 (5.42%) 
1
Term from vocabulary, MedDRA 22.1
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: NCT03028740    
Other Study ID Numbers: 3152-301-002
2016-004566-26 ( EudraCT Number )
1001 ( Registry Identifier: Registro Nacional Estudios Clinicos (RNEC) )
First Submitted: January 13, 2017
First Posted: January 23, 2017
Results First Submitted: January 4, 2022
Results First Posted: March 10, 2022
Last Update Posted: March 10, 2022