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Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis (CENTAUR)

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ClinicalTrials.gov Identifier: NCT02217475
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis
Interventions Drug: Cenicriviroc
Drug: Placebo
Enrollment 289
Recruitment Details  
Pre-assignment Details In total, 812 participants were screened, and 289 participants were randomized to treatment period 1. Of the 289 participants randomized, 250 participants completed Treatment Period 1. A total of 242 participants entered Treatment Period 2 and 212 completed.
Arm/Group Title Placebo/Placebo Placebo/Cenicriviroc (CVC) 150 mg CVC 150mg/CVC 150 mg
Hide Arm/Group Description Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2. Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2. CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
Period Title: Treatment Period 1 (Year 1)
Started 72 72 145
Safety Analysis Set [1] 72 72 144
Completed 62 64 124
Not Completed 10 8 21
Reason Not Completed
Protocol Deviation (with non-compliance)             0             1             0
Adverse Event             4             5             9
Lost to Follow-up             1             0             0
Subject Withdrew Consent             5             2             11
Other Miscellaneous Reasons             0             0             1
[1]
Received at least one dose of study drug.
Period Title: Discontinued After Period 1
Started 62 64 124
Completed 60 61 121
Not Completed 2 3 3
Reason Not Completed
Adverse Event             1             2             0
Participant Withdrew Consent             1             1             2
Physician Decision             0             0             1
Period Title: Treatment Period 2 (Year 2)
Started 60 61 121
Completed 58 59 109
Not Completed 2 2 12
Reason Not Completed
Adverse Event             0             1             5
Lost to Follow-up             0             1             2
Subject Withdrew Consent             2             0             2
Physician Decision             0             0             2
Other Miscellaneous Reasons             0             0             1
Arm/Group Title CVC 150mg/CVC 150 mg Placebo/Cenicriviroc (CVC) 150 mg Placebo/Placebo Total
Hide Arm/Group Description CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2. Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2. Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2. Total of all reporting groups
Overall Number of Baseline Participants 145 72 72 289
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 72 participants 72 participants 289 participants
54.6  (10.22) 55.3  (10.38) 52.1  (11.37) 54.1  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 72 participants 72 participants 289 participants
Female
73
  50.3%
39
  54.2%
40
  55.6%
152
  52.6%
Male
72
  49.7%
33
  45.8%
32
  44.4%
137
  47.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 72 participants 72 participants 289 participants
Hispanic or Latino
23
  15.9%
18
  25.0%
7
   9.7%
48
  16.6%
Not Hispanic or Latino
122
  84.1%
51
  70.8%
65
  90.3%
238
  82.4%
Not reported
0
   0.0%
2
   2.8%
0
   0.0%
2
   0.7%
Unknown
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 72 participants 72 participants 289 participants
Asian
6
   4.1%
6
   8.3%
9
  12.5%
21
   7.3%
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.4%
1
   0.3%
Black or African American
5
   3.4%
1
   1.4%
2
   2.8%
8
   2.8%
Native Hawaiian or Other Pacific Islander
3
   2.1%
0
   0.0%
0
   0.0%
3
   1.0%
White
129
  89.0%
63
  87.5%
58
  80.6%
250
  86.5%
Other
2
   1.4%
2
   2.8%
2
   2.8%
6
   2.1%
1.Primary Outcome
Title Number of Participant With Hepatic Histological Improvement in NAS by ≥ 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1
Hide Description Hepatic histological improvement in Nonalcoholic Fatty Liver Disease Activity Score (NAS) at Year 1 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 145
Measure Type: Count of Participants
Unit of Measure: Participants
27
  18.8%
23
  15.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5194
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.816
Confidence Interval (2-Sided) 95%
0.439 to 1.516
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Hide Description Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants regardless of starting treatment.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 145
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.8%
7
   4.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0388
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.934
Confidence Interval (2-Sided) 95%
1.035 to 3.614
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Hide Description Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 57 178
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.5%
5
   2.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5920
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.249
Confidence Interval (2-Sided) 95%
0.553 to 2.821
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1
Hide Description Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants regardless of starting treatment.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 145
Measure Type: Count of Participants
Unit of Measure: Participants
8
   5.6%
11
   7.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4941
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.396
Confidence Interval (2-Sided) 95%
0.537 to 3.628
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2
Hide Description Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 57 178
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.3%
11
   6.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8434
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.142
Confidence Interval (2-Sided) 95%
0.305 to 4.277
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Hide Description The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants regardless of starting treatment.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 145
Measure Type: Count of Participants
Unit of Measure: Participants
15
  10.4%
29
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0234
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.201
Confidence Interval (2-Sided) 95%
1.113 to 4.352
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Hide Description The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set Year 2 included all participants who have an evaluable year 1 biopsy and who received at least one dose of study drug during Year 2 (after the 1 year biopsy).
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 57 178
Measure Type: Count of Participants
Unit of Measure: Participants
8
  14.0%
27
  15.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, CVC 150 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7474
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.154
Confidence Interval (2-Sided) 95%
0.484 to 2.752
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation
Hide Description A TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 30 days after the discontinuation of the study medication. An SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame Years 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
Arm/Group Title CVC 150 mg/CVC 150 mg Placebo/CVC 150 mg Placebo/Placebo
Hide Arm/Group Description:
CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed 144 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
Deaths
0
   0.0%
0
   0.0%
0
   0.0%
TEAEs
137
  95.1%
68
  94.4%
70
  97.2%
SAEs
25
  17.4%
8
  11.1%
12
  16.7%
TEAEs Leading Study Drug to Discontinuation
14
   9.7%
8
  11.1%
5
   6.9%
9.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs
Hide Description Vital signs included blood pressure, temperature, heart rate, and respiration rate. Vital signs were reviewed by the Investigator for clinically significant changes.
Time Frame Years 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
Arm/Group Title CVC 150 mg/CVC 150 mg Placebo/CVC 150 mg Placebo/Placebo
Hide Arm/Group Description:
CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed 144 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities
Hide Description Grade 3-4 abnormal clinical laboratory values that occurred in ≥2% participants were reported. Criteria used for various parameters was:Fasting glucose Grade3:>250 – 500 mg/dL and Grade4: >500 mg/dL; Alanine aminotransferase(ALT)Grade3:>5.0 – 20.0 ×Upper Limit of Normal(ULN)and Grade4:>20.0 ×ULN; Aspartate aminotransferase(AST)Grade3: >5.0 – 20.0 ×ULN and Grade4: >20.0 ×ULN; Activated partial thromboplastin(APT)/Partial thromboplastin time(PTT)Grade3: >2.5×ULN; Triglycerides Grade3 >500 – 1000 mg/dL and Grade4: >1000 mg/dL; Gamma-glutamyl transferase(GGT)Grade3: >5.0 – 20.0 ×ULN and Grade4: >20.0 ×ULN; Creatine kinase Grade 3: >5.0 – 10.0 ×ULN and Grade4: >10.0 ×ULN; Uric acid Grade3:(ULN – 10 mg/dL; ULN – 0.59 mmol/L) and Grade4: >10 mg/dL; Amylase Grade3: >2.0 – 5.0 ×ULN and Grade4: >5.0 ×ULN; Lipase Grade3: >2.0 – 5.0 xULN and Grade4: >5.0 xULN; Phosphorus Grade3: <2.0 – 1.0 mg/dL and Grade4: <1.0 mg/dL and Absolute neutrophil Grade3: <1.0 – 0.5 × 109/L and Grade4: <0.5 × 109/L.
Time Frame Years 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
Arm/Group Title CVC 150 mg (Year 1) Placebo (Year 1) CVC 150 mg Placebo Then CVC 150 mg Placebo Then Placebo
Hide Arm/Group Description:
CVC 150 mg tablet, once daily in the morning with food in Year 1.
Placebo-matching cenicriviroc tablet once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2. Includes AEs that occurred in Year 2.
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2. Includes AEs that occurred in Year 2.
Overall Number of Participants Analyzed 144 144 121 61 60
Measure Type: Count of Participants
Unit of Measure: Participants
Fasting glucose (Grade 3)
17
  11.8%
13
   9.0%
10
   8.3%
6
   9.8%
5
   8.3%
Fasting glucose (Grade 4)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT (Grade 3)
17
  11.8%
17
  11.8%
4
   3.3%
3
   4.9%
2
   3.3%
ALT (Grade 4)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST (Grade 3)
7
   4.9%
10
   6.9%
1
   0.8%
3
   4.9%
1
   1.7%
AST (Grade 4)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
APT/PTT (Grade 3)
4
   2.8%
2
   1.4%
1
   0.8%
1
   1.6%
2
   3.3%
Triglycerides (Grade 3)
5
   3.5%
7
   4.9%
6
   5.0%
5
   8.2%
2
   3.3%
Triglycerides (Grade 4)
3
   2.1%
3
   2.1%
2
   1.7%
0
   0.0%
1
   1.7%
GGT (Grade 3)
8
   5.6%
7
   4.9%
8
   6.6%
2
   3.3%
2
   3.3%
GGT (Grade 4)
1
   0.7%
1
   0.7%
1
   0.8%
0
   0.0%
0
   0.0%
Creatine kinase (Grade 3)
6
   4.2%
7
   4.9%
1
   0.8%
2
   3.3%
4
   6.7%
Creatine kinase (Grade 4)
2
   1.4%
2
   1.4%
3
   2.5%
1
   1.6%
0
   0.0%
Uric acid (Grade 3)
9
   6.3%
8
   5.6%
4
   3.3%
3
   4.9%
2
   3.3%
Uric acid (Grade 4)
11
   7.6%
6
   4.2%
5
   4.1%
1
   1.6%
6
  10.0%
Amylase (Grade 3)
6
   4.2%
1
   0.7%
4
   3.3%
0
   0.0%
1
   1.7%
Amylase (Grade 4)
3
   2.1%
0
   0.0%
2
   1.7%
0
   0.0%
0
   0.0%
Lipase (Grade 3)
4
   2.8%
2
   1.4%
3
   2.5%
0
   0.0%
1
   1.7%
Lipase (Grade 4)
5
   3.5%
0
   0.0%
3
   2.5%
0
   0.0%
1
   1.7%
Phosphorus (Grade 3)
5
   3.5%
2
   1.4%
2
   1.7%
1
   1.6%
1
   1.7%
Phosphorus (Grade 4)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Absolute neutrophil (Grade 3)
2
   1.4%
3
   2.1%
3
   2.5%
0
   0.0%
1
   1.7%
Absolute neutrophil (Grade 4)
2
   1.4%
1
   0.7%
1
   0.8%
1
   1.6%
1
   1.7%
11.Secondary Outcome
Title Number of Participants With Clinically Abnormal in Electrocardiogram (ECG) Findings
Hide Description A 12-lead ECG was performed. ECG results were reviewed by the Investigator for clinically notable abnormalities.
Time Frame Years 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
Arm/Group Title CVC 150 mg/CVC 150 mg Placebo/CVC 150 mg Placebo/Placebo
Hide Arm/Group Description:
CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.
Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed 144 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Hepatic Histological Improvement in NAS at Year 2
Hide Description Hepatic histological improvement in NAS at Year 2 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Measure Type: Count of Participants
Unit of Measure: Participants
7
   9.7%
24
  11.2%
13.Secondary Outcome
Title Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 1
Hide Description NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 – 33%, 2= >33 – 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Steatosis) 1.4  (0.55) 1.3  (0.57)
Change from Baseline (Steatosis) -0.1  (0.66) -0.2  (0.56)
Baseline (Lobular Inflammation) 2.5  (0.56) 2.4  (0.58)
Change from Baseline (Lobular Inflammation) -0.1  (0.79) -0.1  (0.88)
Baseline (Hepatocellular Ballooning) 1.5  (0.50) 1.5  (0.50)
Change from Baseline (Hepatocellular Ballooning) -0.2  (0.75) -0.1  (0.75)
14.Secondary Outcome
Title Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 2
Hide Description NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 – 33%, 2= >33 – 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 54 159
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (Steatosis) 1.5  (0.54) 1.3  (0.52)
Change from Baseline (Steatosis) -0.4  (0.56) -0.2  (0.50)
Baseline (Lobular Inflammation) 2.4  (0.63) 2.4  (0.54)
Change from Baseline (Lobular Inflammation) 0.1  (0.72) 0.0  (0.84)
Baseline (Hepatocellular Ballooning) 1.5  (0.50) 1.5  (0.50)
Change from Baseline (Hepatocellular Ballooning) -0.1  (0.68) 0.0  (0.83)
15.Secondary Outcome
Title Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-Point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Hide Description Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Measure Type: Count of Participants
Unit of Measure: Participants
24
  16.8%
22
  15.3%
16.Secondary Outcome
Title Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Hide Description Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Measure Type: Count of Participants
Unit of Measure: Participants
6
   8.3%
20
   9.3%
17.Secondary Outcome
Title Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Hide Description Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Measure Type: Count of Participants
Unit of Measure: Participants
7
   4.9%
6
   4.2%
18.Secondary Outcome
Title Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Hide Description Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
9
   4.2%
19.Secondary Outcome
Title Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 1
Hide Description The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 1. A negative change from Baseline indicates improvement.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: percent collagen area
Baseline 2.49  (2.004) 2.37  (1.827)
Change from Baseline to Year 1 -0.14  (2.389) 0.02  (2.357)
20.Secondary Outcome
Title Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 2
Hide Description The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 2. A negative change from Baseline indicates improvement.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 51 150
Mean (Standard Deviation)
Unit of Measure: percent collagen area
Baseline 2.57  (2.156) 2.48  (1.892)
Change from Baseline to Year 2 -0.17  (2.576) -0.09  (2.160)
21.Secondary Outcome
Title Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 1
Hide Description The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 1. A positive change from Baseline indicates worsening.
Time Frame Baseline (Day 1) to Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 122 122
Mean (Standard Deviation)
Unit of Measure: percentage of α-SMA positive cells/area
Baseline 2.41  (2.264) 2.49  (2.885)
Change from Baseline to Year 1 0.77  (3.529) 0.79  (3.861)
22.Secondary Outcome
Title Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 2
Hide Description The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 2. A positive change from Baseline indicates worsening.
Time Frame Baseline (Day 1) to Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 52 152
Mean (Standard Deviation)
Unit of Measure: percentage of α-SMA positive cells/area
Baseline 2.47  (2.679) 2.44  (2.505)
Change from Baseline to Year 2 2.10  (4.533) 1.38  (3.793)
23.Secondary Outcome
Title Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 1
Hide Description The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 1. A negative change from Baseline indicates improvement.
Time Frame Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 123 121
Mean (Standard Deviation)
Unit of Measure: percent fat area
Baseline 22.42  (10.016) 21.58  (8.740)
Change from Baseline to Year 1 -3.39  (9.120) -2.79  (8.127)
24.Secondary Outcome
Title Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 2
Hide Description The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 2. A negative change from Baseline indicates improvement.
Time Frame Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 50 150
Mean (Standard Deviation)
Unit of Measure: percent fat area
Baseline 23.30  (10.300) 21.62  (9.575)
Change from Baseline to Year 2 -5.06  (9.739) -2.96  (9.230)
25.Secondary Outcome
Title Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 1
Hide Description The participant’s histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A positive change from Baseline indicates worsening.
Time Frame Baseline (Day 1) to Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 126 126
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (NASH CRN Fibrosis Stage) 2.1  (0.86) 2.0  (0.85)
Change from Baseline (NASH CRN Fibrosis Stage) 0.2  (0.92) 0.0  (1.00)
Baseline (Ishak Fibrosis Stage) 2.2  (1.00) 2.2  (1.05)
Change from Baseline (Ishak Fibrosis Stage) 0.2  (1.10) 0.0  (1.20)
26.Secondary Outcome
Title Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 2
Hide Description The participant’s histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A negative change from Baseline indicates improvement.
Time Frame Baseline (Day 1) to Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 54 159
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (NASH CRN Fibrosis Stage) 2.0  (0.88) 2.1  (0.85)
Change from Baseline (NASH CRN Fibrosis Stage) 0.0  (0.89) 0.0  (1.08)
Baseline (Ishak Fibrosis Stage) 2.1  (1.00) 2.2  (1.04)
Change from Baseline (Ishak Fibrosis Stage) 0.1  (1.21) 0.0  (1.26)
27.Secondary Outcome
Title Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 1
Hide Description Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.
Time Frame Baseline (Day 1) to Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 126 124
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.6  (0.63) 1.5  (0.64)
Change from Baseline to Year 1 0.0  (0.76) 0.2  (0.74)
28.Secondary Outcome
Title Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 2
Hide Description Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.
Time Frame Baseline (Day 1) to Year 2
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 54 159
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 1.5  (0.64) 1.6  (0.67)
Change from Baseline to Year 1 0.1  (0.75) 0.2  (0.72)
29.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 3, 6 and 12
Hide Description APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (Month 3) Number Analyzed 127 participants 133 participants
0.649  (0.3661) 0.596  (0.4089)
Change from Baseline to Month 3 Number Analyzed 127 participants 133 participants
-0.005  (0.3012) 0.065  (0.3152)
Baseline (Month 6) Number Analyzed 128 participants 127 participants
0.663  (0.3811) 0.578  (0.3794)
Change from Baseline to Month 6 Number Analyzed 128 participants 127 participants
0.009  (0.3968) 0.102  (0.4536)
Baseline (Month 12) Number Analyzed 117 participants 117 participants
0.662  (0.3915) 0.580  (0.3939)
Change from Baseline to Month 12 Number Analyzed 117 participants 117 participants
0.066  (0.5572) 0.093  (0.3852)
30.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 15, 18 and 24
Hide Description APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (Month 15) Number Analyzed 59 participants 167 participants
0.619  (0.3157) 0.584  (0.3572)
Change from Baseline to Month 15 Number Analyzed 59 participants 167 participants
0.002  (0.3422) 0.118  (0.4095)
Baseline (Month 18) Number Analyzed 53 participants 167 participants
0.620  (0.3305) 0.586  (0.3612)
Change from Baseline to Month 18 Number Analyzed 53 participants 167 participants
0.038  (0.4033) 0.133  (0.4269)
Baseline (Month 24) Number Analyzed 56 participants 158 participants
0.633  (0.3156) 0.584  (0.3617)
Change from Baseline to Month 24 Number Analyzed 56 participants 158 participants
-0.020  (0.4721) 0.086  (0.4153)
31.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 3, 6 and 12
Hide Description Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.
Time Frame Baseline (Month 0) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (Month 3) Number Analyzed 127 participants 133 participants
1.444  (0.6753) 1.417  (0.6893)
Change from Baseline to Month 3 Number Analyzed 127 participants 133 participants
0.021  (0.4236) 0.071  (0.4209)
Baseline (Month 6) Number Analyzed 128 participants 127 participants
1.500  (0.7268) 1.388  (0.6771)
Change from Baseline to Month 6 Number Analyzed 128 participants 127 participants
0.015  (0.4591) 0.099  (0.5246)
Baseline (Month 12) Number Analyzed 117 participants 117 participants
1.503  (0.7442) 1.398  (0.6834)
Change from Baseline to Month 12 Number Analyzed 117 participants 117 participants
0.106  (0.6876) 0.117  (0.5069)
32.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 15, 18 and 24
Hide Description Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.
Time Frame Baseline (Month 0) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline (Month 15) Number Analyzed 59 participants 167 participants
1.409  (0.6706) 1.440  (0.6714)
Change from Baseline to Month 15 Number Analyzed 59 participants 167 participants
0.075  (0.5982) 0.213  (0.6462)
Baseline (Month 18) Number Analyzed 53 participants 167 participants
1.389  (0.6699) 1.440  (0.6895)
Change from Baseline to Month 18 Number Analyzed 53 participants 167 participants
0.094  (0.5891) 0.219  (0.5559)
Baseline (Month 24) Number Analyzed 56 participants 158 participants
1.426  (0.6841) 1.444  (0.6838)
Change from Baseline to Month 24 Number Analyzed 56 participants 158 participants
0.064  (0.8103) 0.166  (0.6086)
33.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 6 and 12
Hide Description Hyaluronic acid is a non-invasive hepatic fibrosis marker. A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 6) Number Analyzed 128 participants 128 participants
68.7  (107.63) 68.2  (78.88)
Change from Baseline to Month 6 Number Analyzed 128 participants 128 participants
-2.4  (75.03) 10.7  (79.58)
Baseline (Month 12) Number Analyzed 122 participants 121 participants
70.7  (110.49) 69.5  (80.56)
Change from Baseline to Month 12 Number Analyzed 122 participants 121 participants
-0.2  (81.30) 10.9  (58.46)
34.Secondary Outcome
Title Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 18 and 24
Hide Description Hyaluronic acid is a non-invasive hepatic fibrosis marker. A positive change from Baseline indicates increased fibrosis.
Time Frame Baseline (Month 0) to Months 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 18) Number Analyzed 58 participants 170 participants
46.4  (32.67) 79.6  (111.36)
Change from Baseline to Month 18 Number Analyzed 58 participants 170 participants
5.7  (34.66) 1.4  (81.20)
Baseline (Month 24) Number Analyzed 57 participants 164 participants
46.6  (32.91) 79.7  (112.46)
Change from Baseline to Month 24 Number Analyzed 57 participants 164 participants
19.3  (70.64) 13.0  (95.00)
35.Secondary Outcome
Title Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) at Months 3, 6 and 12
Hide Description NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio – 0.013 × platelet (*10^9/L) – 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 3) Number Analyzed 125 participants 125 participants
-1.227  (1.5255) -1.012  (1.2558)
Change from Baseline to Month 3 Number Analyzed 125 participants 125 participants
0.029  (0.5150) 0.087  (0.4608)
Baseline (Month 6) Number Analyzed 125 participants 119 participants
-1.119  (1.4935) -1.064  (1.2403)
Change from Baseline to Month 6 Number Analyzed 125 participants 119 participants
0.051  (0.4747) 0.094  (0.5460)
Baseline (Month 12) Number Analyzed 115 participants 108 participants
-1.132  (1.4609) -1.040  (1.1393)
Change from Baseline to Month 12 Number Analyzed 115 participants 108 participants
0.121  (0.5117) 0.139  (0.5016)
36.Secondary Outcome
Title Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: NAFLD Fibrosis Score (NFS) at Months 15, 18 and 24
Hide Description NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio – 0.013 × platelet (*10^9/L) – 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 15) Number Analyzed 59 participants 158 participants
-1.252  (1.4602) -1.051  (1.3410)
Change from Baseline to Month 15 Number Analyzed 59 participants 158 participants
0.057  (0.5981) 0.225  (0.5654)
Baseline (Month 18) Number Analyzed 53 participants 158 participants
-1.284  (1.4910) -1.057  (1.3309)
Change from Baseline to Month 18 Number Analyzed 53 participants 158 participants
0.046  (0.5809) 0.196  (0.5583)
Baseline (Month 24) Number Analyzed 54 participants 147 participants
-1.245  (1.4778) -1.100  (1.3228)
Change from Baseline to Month 24 Number Analyzed 54 participants 147 participants
0.046  (0.6188) 0.185  (0.6184)
37.Secondary Outcome
Title Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 6 and 12
Hide Description The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 6) Number Analyzed 125 participants 125 participants
-0.786  (0.7179) -0.837  (0.7238)
Change from Baseline to Month 6 Number Analyzed 125 participants 125 participants
-0.022  (0.4901) 0.060  (0.5228)
Baseline (Month 12) Number Analyzed 116 participants 118 participants
-0.795  (0.7435) -0.801  (0.7162)
Change from Baseline to Month 12 Number Analyzed 116 participants 118 participants
-0.064  (0.5602) 0.041  (0.5727)
38.Secondary Outcome
Title Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 18 and 24
Hide Description The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame Baseline (Month 0) to Months 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Month 18) Number Analyzed 57 participants 164 participants
-0.931  (0.6387) -0.758  (0.7307)
Change from Baseline to Month 18 Number Analyzed 57 participants 164 participants
-0.129  (0.6606) -0.087  (0.6113)
Baseline (Month 24) Number Analyzed 56 participants 157 participants
-0.940  (0.6587) -0.765  (0.7127)
Change from Baseline to Month 24 Number Analyzed 56 participants 157 participants
-0.024  (0.7375) 0.096  (0.6437)
39.Secondary Outcome
Title Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 3, 6 and 12
Hide Description Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.
Time Frame Baseline (Month 0) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 143 144
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (Month 3) Number Analyzed 115 participants 119 participants
601.6  (431.77) 594.2  (554.20)
Change from Baseline to Month 3 Number Analyzed 115 participants 119 participants
-56.4  (451.14) -59.0  (485.76)
Baseline (Month 6) Number Analyzed 105 participants 107 participants
550.3  (360.64) 552.9  (393.92)
Change from Baseline to Month 6 Number Analyzed 105 participants 107 participants
10.6  (461.98) -26.1  (512.88)
Baseline (Month 12) Number Analyzed 107 participants 101 participants
555.3  (356.28) 567.9  (500.53)
Change from Baseline to Month 12 Number Analyzed 107 participants 101 participants
99.7  (824.50) 107.8  (830.28)
40.Secondary Outcome
Title Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 15, 18 and 24
Hide Description Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.
Time Frame Baseline (Month 0) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 72 215
Mean (Standard Deviation)
Unit of Measure: U/L
CK-18(M30), Baseline (Month 15) Number Analyzed 51 participants 145 participants
570.8  (297.42) 536.4  (459.06)
CK-18(M30), Change from Baseline to Month 15 Number Analyzed 51 participants 145 participants
-39.6  (287.44) -13.3  (450.16)
CK-18(M30), Baseline (Month 18) Number Analyzed 51 participants 149 participants
578.8  (293.93) 540.9  (453.90)
CK-18(M30), Change from Baseline to Month 18 Number Analyzed 51 participants 149 participants
23.8  (402.98) 57.3  (476.92)
CK-18(M30), Baseline (Month 24) Number Analyzed 50 participants 143 participants
575.4  (293.64) 541.8  (462.29)
CK-18(M30), Change from Baseline to Month 24 Number Analyzed 50 participants 143 participants
-30.0  (369.60) 39.7  (437.60)
CK-18(M65), Baseline (Month 15) Number Analyzed 51 participants 145 participants
772.7  (337.24) 687.4  (404.83)
CK-18(M65), Change from Baseline to Month 15 Number Analyzed 51 participants 145 participants
134.7  (534.46) 88.6  (559.11)
CK-18(M65), Baseline (Month 18) Number Analyzed 51 participants 149 participants
777.8  (344.07) 694.8  (401.88)
CK-18(M65), Change from Baseline to Month 18 Number Analyzed 51 participants 149 participants
158.0  (732.63) 181.5  (620.57)
CK-18(M65), Baseline (Month 24) Number Analyzed 50 participants 143 participants
770.2  (335.05) 693.9  (409.88)
CK-18(M65), Change from Baseline to Month 24 Number Analyzed 50 participants 143 participants
7.4  (570.92) 124.9  (522.08)
41.Secondary Outcome
Title Change From Baseline in Weight at Months 3, 6 and 12
Hide Description A negative change from Baseline represents decreased weight.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (Month 3) Number Analyzed 133 participants 138 participants
97.21  (22.368) 95.59  (20.590)
Change from Baseline to Month 3 Number Analyzed 133 participants 138 participants
-0.50  (2.652) -0.63  (2.632)
Baseline (Month 6) Number Analyzed 130 participants 132 participants
97.18  (22.224) 95.18  (20.386)
Change from Baseline to Month 6 Number Analyzed 130 participants 132 participants
-0.55  (3.319) -0.47  (3.466)
Baseline (Month 12) Number Analyzed 126 participants 122 participants
96.63  (22.139) 95.06  (20.651)
Change from Baseline to Month 12 Number Analyzed 126 participants 122 participants
-0.08  (4.301) -0.28  (4.166)
42.Secondary Outcome
Title Change From Baseline in Weight at Months 15, 18 and 24
Hide Description A negative change from Baseline represents decreased weight.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: kg
Baseline (Month 15) Number Analyzed 59 participants 174 participants
98.25  (24.087) 95.32  (20.749)
Change from Baseline to Month 15 Number Analyzed 59 participants 174 participants
0.15  (3.448) -0.44  (4.257)
Baseline (Month 18) Number Analyzed 58 participants 173 participants
96.98  (22.210) 95.23  (20.823)
Change from Baseline to Month 18 Number Analyzed 58 participants 173 participants
0.05  (4.194) -0.16  (4.458)
Baseline (Month 24) Number Analyzed 58 participants 166 participants
96.98  (22.210) 95.19  (20.972)
Change from Baseline to Month 24 Number Analyzed 58 participants 166 participants
-0.91  (5.649) -0.56  (5.081)
43.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Months 3, 6 and 12
Hide Description The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Baseline (Month 3) Number Analyzed 133 participants 135 participants
34.129  (7.2492) 33.706  (5.7812)
Change from Baseline to Month 3 Number Analyzed 133 participants 135 participants
-0.172  (0.9200) -0.232  (0.9500)
Baseline (Month 6) Number Analyzed 130 participants 129 participants
34.196  (7.3086) 33.547  (5.6037)
Change from Baseline to Month 6 Number Analyzed 130 participants 129 participants
-0.182  (1.1558) -0.196  (1.2500)
Baseline (Month 12) Number Analyzed 126 participants 119 participants
34.029  (7.1358) 33.374  (5.6631)
Change from Baseline to Month 12 Number Analyzed 126 participants 119 participants
-0.013  (1.7507) -0.145  (1.4891)
44.Secondary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Months 15, 18 and 24
Hide Description The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Baseline (Month 15) Number Analyzed 59 participants 171 participants
34.713  (8.0431) 33.392  (5.9669)
Change from Baseline to Month 15 Number Analyzed 59 participants 171 participants
-0.006  (1.2799) -0.113  (1.6311)
Baseline (Month 18) Number Analyzed 58 participants 170 participants
34.473  (7.8964) 33.345  (5.9443)
Change from Baseline to Month 18 Number Analyzed 58 participants 170 participants
-0.039  (1.5931) -0.040  (1.7153)
Baseline (Month 24) Number Analyzed 58 participants 163 participants
34.473  (7.8964) 33.278  (6.0012)
Change from Baseline to Month 24 Number Analyzed 58 participants 163 participants
-0.393  (2.0613) -0.178  (1.8515)
45.Secondary Outcome
Title Change From Baseline in Waist Circumference at Months 3, 6 and 12
Hide Description A negative change from Baseline represents decreased in waist circumference.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 3) Number Analyzed 131 participants 135 participants
110.35  (14.866) 110.25  (13.406)
Change from Baseline to Month 3 Number Analyzed 131 participants 135 participants
0.07  (5.147) 0.05  (5.396)
Baseline (Month 6) Number Analyzed 129 participants 129 participants
110.42  (14.986) 110.12  (13.561)
Change from Baseline to Month 6 Number Analyzed 129 participants 129 participants
0.42  (8.827) -0.54  (5.876)
Baseline (Month 12) Number Analyzed 123 participants 118 participants
109.77  (14.617) 110.02  (13.711)
Change from Baseline to Month 12 Number Analyzed 123 participants 118 participants
0.44  (6.584) -1.10  (6.255)
46.Secondary Outcome
Title Change From Baseline in Waist Circumference at Months 15, 18 and 24
Hide Description A negative change from Baseline represents decreased in waist circumference.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 15) Number Analyzed 57 participants 172 participants
110.19  (14.360) 110.26  (14.486)
Change from Baseline to Month 15 Number Analyzed 57 participants 172 participants
0.52  (5.520) -0.18  (6.280)
Baseline (Month 18) Number Analyzed 56 participants 170 participants
109.48  (12.703) 110.25  (14.517)
Change from Baseline to Month 18 Number Analyzed 56 participants 170 participants
1.36  (7.966) -0.21  (6.578)
Baseline (Month 24) Number Analyzed 58 participants 163 participants
109.36  (12.608) 110.08  (14.606)
Change from Baseline to Month 24 Number Analyzed 58 participants 163 participants
0.11  (7.907) -1.00  (6.503)
47.Secondary Outcome
Title Change From Baseline in Hip Circumference at Months 3, 6 and 12
Hide Description A negative change from Baseline represents decreased hip circumference.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 3) Number Analyzed 129 participants 130 participants
114.92  (16.150) 112.35  (13.802)
Change from Baseline to Month 3 Number Analyzed 129 participants 130 participants
-0.30  (4.921) -0.11  (6.475)
Baseline (Month 6) Number Analyzed 127 participants 124 participants
115.09  (16.270) 112.16  (13.320)
Change from Baseline to Month 6 Number Analyzed 127 participants 124 participants
-0.84  (4.396) -0.18  (5.715)
Baseline (Month 12) Number Analyzed 121 participants 113 participants
114.46  (15.970) 111.66  (13.376)
Change from Baseline to Month 12 Number Analyzed 121 participants 113 participants
-0.25  (5.876) -0.08  (7.474)
48.Secondary Outcome
Title Change From Baseline in Hip Circumference at Months 15, 18 and 24
Hide Description A negative change from Baseline represents decreased hip circumference.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 15) Number Analyzed 58 participants 165 participants
114.56  (17.500) 113.00  (14.183)
Change from Baseline to Month 15 Number Analyzed 58 participants 165 participants
-0.06  (5.361) -0.83  (7.050)
Baseline (Month 18) Number Analyzed 55 participants 162 participants
114.28  (17.871) 112.70  (14.168)
Change from Baseline to Month 18 Number Analyzed 55 participants 162 participants
0.55  (7.791) -0.90  (6.066)
Baseline (Month 24) Number Analyzed 58 participants 157 participants
114.34  (17.408) 112.88  (14.225)
Change from Baseline to Month 24 Number Analyzed 58 participants 157 participants
-0.95  (7.700) -1.21  (6.677)
49.Secondary Outcome
Title Change From Baseline in Forearm Circumference at Months 3, 6 and 12
Hide Description A negative change from Baseline represents decreased forearm circumference.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 3) Number Analyzed 127 participants 132 participants
32.95  (7.346) 33.38  (4.835)
Change from Baseline to Month 3 Number Analyzed 127 participants 132 participants
0.97  (6.023) 0.10  (6.486)
Baseline (Month 6) Number Analyzed 126 participants 126 participants
32.70  (7.290) 33.25  (4.734)
Change from Baseline to Month 6 Number Analyzed 126 participants 126 participants
0.82  (6.748) -0.01  (3.447)
Baseline (Month 12) Number Analyzed 120 participants 115 participants
32.51  (7.277) 33.09  (4.771)
Change from Baseline to Month 12 Number Analyzed 120 participants 115 participants
0.83  (6.656) -0.43  (3.516)
50.Secondary Outcome
Title Change From Baseline in Forearm Circumference at Months 15, 18 and 24
Hide Description A negative change from Baseline represents decreased forearm circumference.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: cm
Baseline (Month 15) Number Analyzed 57 participants 168 participants
32.88  (7.783) 32.91  (5.662)
Change from Baseline to Month 15 Number Analyzed 57 participants 168 participants
1.61  (6.534) 0.01  (5.052)
Baseline (Month 18) Number Analyzed 55 participants 166 participants
32.63  (7.718) 32.87  (5.696)
Change from Baseline to Month 18 Number Analyzed 55 participants 166 participants
1.79  (6.715) 0.02  (4.709)
Baseline (Month 24) Number Analyzed 57 participants 159 participants
32.79  (7.660) 33.02  (5.561)
Change from Baseline to Month 24 Number Analyzed 57 participants 159 participants
0.78  (6.124) -0.64  (4.408)
51.Secondary Outcome
Title Change From Baseline in Tricep Skinfold Thickness at Months 3, 6 and 12
Hide Description A negative change from Baseline represents decreased Tricep Skinfold Thickness.
Time Frame Baseline (Day 1) to Months 3, 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.
Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed 144 144
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (Month 3) Number Analyzed 127 participants 131 participants
28.32  (13.677) 25.41  (12.593)
Change from Baseline to Month 3 Number Analyzed 127 participants 131 participants
-1.21  (6.548) -0.62  (8.704)
Baseline (Month 6) Number Analyzed 128 participants 125 participants
28.53  (13.763) 25.38  (12.769)
Change from Baseline to Month 6 Number Analyzed 128 participants 125 participants
-2.72  (8.091) -1.52  (9.287)
Baseline (Month 12) Number Analyzed 122 participants 115 participants
28.54  (13.981) 25.14  (12.969)
Change from Baseline to Month 12 Number Analyzed 122 participants 115 participants
-1.34  (9.389) -0.26  (10.653)
52.Secondary Outcome
Title Change From Baseline in Tricep Skinfold Thickness at Months 15, 18 and 24
Hide Description A negative change from Baseline represents decreased Tricep Skinfold Thickness.
Time Frame Baseline (Day 1) to Months 15, 18 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.
Arm/Group Title Placebo CVC 150 mg
Hide Arm/Group Description:
Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.
Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed 60 182
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (Month 15) Number Analyzed 57 participants 170 participants
29.84  (14.422) 25.41  (13.212)
Change from Baseline to Month 15 Number Analyzed 57 participants 170 participants
-1.45  (9.364) -1.59  (8.918)
Baseline (Month 18) Number Analyzed 55 participants 168 participants
29.84  (14.655) 25.07  (12.856)
Change from Baseline to Month 18 Number Analyzed 55 participants 168 participants
-2.27  (8.854) -2.64  (8.864)
Baseline (Month 24) Number Analyzed 56 participants 160 participants
29.91  (14.532) 24.82  (13.025)
Change from Baseline to Month 24 Number Analyzed 56 participants 160 participants
-3.11  (8.553) -1.33  (10.521)
Time Frame Baseline to Year 2
Adverse Event Reporting Description Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
 
Arm/Group Title CVC 150mg/CVC 150 mg Placebo/Cenicriviroc (CVC) 150 mg Placebo/Placebo
Hide Arm/Group Description CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2. Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2. Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
All-Cause Mortality
CVC 150mg/CVC 150 mg Placebo/Cenicriviroc (CVC) 150 mg Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/144 (0.00%)   0/72 (0.00%)   0/72 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CVC 150mg/CVC 150 mg Placebo/Cenicriviroc (CVC) 150 mg Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/144 (17.36%)   8/72 (11.11%)   12/72 (16.67%) 
Blood and lymphatic system disorders       
Anaemia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Cardiac disorders       
Acute coronary syndrome  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Acute myocardial infarction  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Arrhythmia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Cardiac failure congestive  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Coronary artery occlusion  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Myocardial ischaemia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Gastrointestinal disorders       
Inguinal hernia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Pancreatitis acute  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Abdominal pain upper  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Colitis ischaemic  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Large intestine polyp  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Peritoneal haemorrhage  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Vasculitis gastrointestinal  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
General disorders       
Chest pain  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Non-cardiac chest pain  1  2/144 (1.39%)  0/72 (0.00%)  1/72 (1.39%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Infections and infestations       
Appendicitis  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Cellulitis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Diverticulitis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Gastroenteritis  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Pneumonia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Sepsis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Pyelonephritis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Subcutaneous abscess  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Urosepsis  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Ankle fracture  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Concussion  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Facial bones fracture  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Joint injury  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Laceration  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Lumbar vertebral fracture  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Meniscus injury  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Traumatic haemothorax  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Humerus fracture  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Overdose  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Procedural pain  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Wrist fracture  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Investigations       
Blood triglycerides increased  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Metabolism and nutrition disorders       
Dehydration  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Type 2 diabetes mellitus  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Hypovolaemia  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Spinal osteoarthritis  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Osteoarthritis  1  2/144 (1.39%)  0/72 (0.00%)  0/72 (0.00%) 
Intervertebral disc protrusion  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Lumbar spinal stenosis  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Psoriatic arthropathy  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pancreatic neoplasm  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Peripheral nerve sheath tumour malignant  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Haemangioma of skin  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Nervous system disorders       
Convulsion  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Syncope  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Generalised tonic-clonic seizure  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Loss of consciousness  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Paraesthesia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
VIIth nerve paralysis  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Psychiatric disorders       
Bipolar disorder  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/144 (0.00%)  1/72 (1.39%)  0/72 (0.00%) 
Renal failure  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Renal failure acute  1  0/144 (0.00%)  1/72 (1.39%)  1/72 (1.39%) 
Bladder dysplasia  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Lung disorder  1  1/144 (0.69%)  0/72 (0.00%)  0/72 (0.00%) 
Asthma  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
Vascular disorders       
Deep vein thrombosis  1  0/144 (0.00%)  0/72 (0.00%)  1/72 (1.39%) 
1
Term from vocabulary, MedDRA, Version 17.1
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%
CVC 150mg/CVC 150 mg Placebo/Cenicriviroc (CVC) 150 mg Placebo/Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   127/144 (88.19%)   59/72 (81.94%)   60/72 (83.33%) 
Gastrointestinal disorders       
Diarrhoea  1  32/144 (22.22%)  14/72 (19.44%)  15/72 (20.83%) 
Abdominal pain upper  1  16/144 (11.11%)  12/72 (16.67%)  10/72 (13.89%) 
Abdominal pain  1  18/144 (12.50%)  6/72 (8.33%)  11/72 (15.28%) 
Nausea  1  28/144 (19.44%)  6/72 (8.33%)  8/72 (11.11%) 
Abdominal distension  1  13/144 (9.03%)  4/72 (5.56%)  0/72 (0.00%) 
Constipation  1  13/144 (9.03%)  4/72 (5.56%)  6/72 (8.33%) 
Flatulence  1  9/144 (6.25%)  3/72 (4.17%)  2/72 (2.78%) 
Gastrooesophageal reflux disease  1  6/144 (4.17%)  3/72 (4.17%)  4/72 (5.56%) 
Vomiting  1  18/144 (12.50%)  3/72 (4.17%)  5/72 (6.94%) 
General disorders       
Fatigue  1  24/144 (16.67%)  10/72 (13.89%)  13/72 (18.06%) 
Oedema peripheral  1  5/144 (3.47%)  5/72 (6.94%)  3/72 (4.17%) 
Pyrexia  1  8/144 (5.56%)  4/72 (5.56%)  1/72 (1.39%) 
Infections and infestations       
Urinary tract infection  1  17/144 (11.81%)  10/72 (13.89%)  4/72 (5.56%) 
Nasopharyngitis  1  21/144 (14.58%)  9/72 (12.50%)  7/72 (9.72%) 
Upper respiratory tract infection  1  18/144 (12.50%)  9/72 (12.50%)  8/72 (11.11%) 
Influenza  1  11/144 (7.64%)  3/72 (4.17%)  3/72 (4.17%) 
Sinusitis  1  18/144 (12.50%)  3/72 (4.17%)  9/72 (12.50%) 
Ear infection  1  5/144 (3.47%)  2/72 (2.78%)  4/72 (5.56%) 
Bronchitis  1  10/144 (6.94%)  1/72 (1.39%)  7/72 (9.72%) 
Gastroenteritis  1  3/144 (2.08%)  1/72 (1.39%)  4/72 (5.56%) 
Injury, poisoning and procedural complications       
Procedural pain  1  5/144 (3.47%)  2/72 (2.78%)  9/72 (12.50%) 
Investigations       
Alanine aminotransferase increased  1  15/144 (10.42%)  9/72 (12.50%)  5/72 (6.94%) 
Blood creatine phosphokinase increased  1  3/144 (2.08%)  5/72 (6.94%)  0/72 (0.00%) 
Metabolism and nutrition disorders       
Type 2 diabetes mellitus  1  6/144 (4.17%)  5/72 (6.94%)  4/72 (5.56%) 
Hyperglycaemia  1  0/144 (0.00%)  4/72 (5.56%)  2/72 (2.78%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  11/144 (7.64%)  11/72 (15.28%)  12/72 (16.67%) 
Myalgia  1  11/144 (7.64%)  5/72 (6.94%)  3/72 (4.17%) 
Arthralgia  1  23/144 (15.97%)  4/72 (5.56%)  4/72 (5.56%) 
Muscle spasms  1  15/144 (10.42%)  4/72 (5.56%)  2/72 (2.78%) 
Pain in extremity  1  14/144 (9.72%)  1/72 (1.39%)  6/72 (8.33%) 
Nervous system disorders       
Headache  1  24/144 (16.67%)  15/72 (20.83%)  9/72 (12.50%) 
Dizziness  1  13/144 (9.03%)  0/72 (0.00%)  5/72 (6.94%) 
Psychiatric disorders       
Insomnia  1  10/144 (6.94%)  2/72 (2.78%)  2/72 (2.78%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  16/144 (11.11%)  5/72 (6.94%)  6/72 (8.33%) 
Oropharyngeal pain  1  13/144 (9.03%)  3/72 (4.17%)  4/72 (5.56%) 
Nasal congestion  1  8/144 (5.56%)  0/72 (0.00%)  2/72 (2.78%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  10/144 (6.94%)  3/72 (4.17%)  5/72 (6.94%) 
Rash  1  12/144 (8.33%)  3/72 (4.17%)  8/72 (11.11%) 
Vascular disorders       
Hypertension  1  10/144 (6.94%)  4/72 (5.56%)  3/72 (4.17%) 
1
Term from vocabulary, MedDRA, Version 17.1
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: NCT02217475     History of Changes
Other Study ID Numbers: 652-2-203
2016-004754-15 ( EudraCT Number )
First Submitted: August 13, 2014
First Posted: August 15, 2014
Results First Submitted: April 19, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019