Trial · NCT02217475
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
NCT02217475, Phase 2, Completed, Tobira Therapeutics, Inc.; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis. Trials, record NCT02217475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02217475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
- NCT number
- NCT02217475
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 289 participants, actual
- Lead sponsor
- Tobira Therapeutics, Inc.
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Cenicriviroc, Placebo
- First posted
- 2014-08-15
- Last updated
- 2019-05-10
- Other registries' IDs
- eudract:2016-004754-15
- Results first posted
- 2019-05-10
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Year 1 | 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. |
| Secondary | 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 | Year 1 | 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. |
| Secondary | 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 | Year 2 | 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. |
| Secondary | Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1 | Year 1 | 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. |
| Secondary | Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2 | Year 2 | 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. |
| Secondary | Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1 | 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 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. |
| Secondary | Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2 | Year 2 | 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. |
| Secondary | Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation | Years 1 and 2 | 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. |
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Years 1 and 2 | Vital signs included blood pressure, temperature, heart rate, and respiration rate. Vital signs were reviewed by the Investigator for clinically significant changes. |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | Years 1 and 2 | 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. |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Year 1 | Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Year 1 | ITT population included all randomized participants regardless of starting treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Year 2 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1 | Year 1 | ITT population included all randomized participants regardless of starting treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2 | Year 2 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1 | Year 1 | ITT population included all randomized participants regardless of starting treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2 | Year 2 | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation | Years 1 and 2 | Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Changes in Vital Signs | Years 1 and 2 | Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities | Years 1 and 2 | Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group513
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Placebo | 27 | Participants | ||
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 | CVC 150 mg | 23 | Participants | ||
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 | Placebo | 4 | Participants | ||
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 | CVC 150 mg | 7 | Participants | ||
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 | Placebo | 2 | Participants | ||
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 | CVC 150 mg | 5 | Participants | ||
| Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1 | Placebo | 8 | Participants | ||
| Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1 | CVC 150 mg | 11 | Participants | ||
| Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2 | Placebo | 3 | Participants | ||
| Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2 | CVC 150 mg | 11 | Participants |
1 to 10 of 513Source ClinicalTrials.gov
See all 513 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Year 1) | STARTED | Placebo/Placebo | 72 | |
| Treatment Period 1 (Year 1) | STARTED | Placebo/Cenicriviroc (CVC) 150 mg | 72 | |
| Treatment Period 1 (Year 1) | STARTED | CVC 150mg/CVC 150 mg | 145 | |
| Treatment Period 1 (Year 1) | Safety Analysis Set | Placebo/Placebo | 72 | |
| Treatment Period 1 (Year 1) | Safety Analysis Set | Placebo/Cenicriviroc (CVC) 150 mg | 72 | |
| Treatment Period 1 (Year 1) | Safety Analysis Set | CVC 150mg/CVC 150 mg | 144 | |
| Treatment Period 1 (Year 1) | COMPLETED | Placebo/Placebo | 62 | |
| Treatment Period 1 (Year 1) | COMPLETED | Placebo/Cenicriviroc (CVC) 150 mg | 64 | |
| Treatment Period 1 (Year 1) | COMPLETED | CVC 150mg/CVC 150 mg | 124 | |
| Treatment Period 1 (Year 1) | NOT COMPLETED | Placebo/Placebo | 10 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events318
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | CVC 150mg/CVC 150 mg | 32 | 144 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo/Cenicriviroc (CVC) 150 mg | 14 | 72 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo/Placebo | 15 | 72 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CVC 150mg/CVC 150 mg | 16 | 144 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo/Cenicriviroc (CVC) 150 mg | 12 | 72 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo/Placebo | 10 | 72 | |
| other | Abdominal pain | Gastrointestinal disorders | CVC 150mg/CVC 150 mg | 18 | 144 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo/Cenicriviroc (CVC) 150 mg | 6 | 72 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo/Placebo | 11 | 72 | |
| other | Nausea | Gastrointestinal disorders | CVC 150mg/CVC 150 mg | 28 | 144 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CVC 150mg/CVC 150 mg | 0 | 144 |
| Total, all-cause mortality | Placebo/Cenicriviroc (CVC) 150 mg | 0 | 72 |
| Total, all-cause mortality | Placebo/Placebo | 0 | 72 |
| Total, other adverse events | CVC 150mg/CVC 150 mg | 127 | 144 |
| Total, other adverse events | Placebo/Cenicriviroc (CVC) 150 mg | 59 | 72 |
| Total, other adverse events | Placebo/Placebo | 60 | 72 |
| Total, serious adverse events | CVC 150mg/CVC 150 mg | 25 | 144 |
| Total, serious adverse events | Placebo/Cenicriviroc (CVC) 150 mg | 8 | 72 |
| Total, serious adverse events | Placebo/Placebo | 12 | 72 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
CVC 150 mg vs Placebo: 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 | Trial comparisons |
| CVC 150 mg vs Placebo: Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2 | Trial comparisons |
| CVC 150 mg vs Placebo: Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1 | Trial comparisons |
| CVC 150 mg vs Placebo: Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2 | Trial comparisons |
CVC 150 mg vs Placebo: 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 | Trial comparisons |
CVC 150 mg vs Placebo: 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 | Trial comparisons |
| CVC 150 mg vs Placebo: 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 | Trial comparisons |
| CVC 150 mg vs Placebo: 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 | Trial comparisons |
| CVC 150 mg vs Placebo: Number of Participants With Hepatic Histological Improvement in NAS at Year 2 | Trial comparisons |
CVC 150 mg vs Placebo: 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 | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02217475
GET https://conductscience.org/api/trials/v1/NCT02217475/registered?page=2