Overview

This trial is active, not recruiting.

Condition nonalcoholic steatohepatitis
Treatments cenicriviroc, placebo
Phase phase 2
Sponsor Tobira Therapeutics, Inc.
Start date September 2014
End date June 2016
Trial size 289 participants
Trial identifier NCT02217475, 652-2-203

Summary

The purpose of this study is to determine whether Cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Cenicriviroc 150mg tablet once daily in the morning with food for 2 years
cenicriviroc CVC
CVC 150 mg, administered orally once daily and taken every morning with food
(Experimental)
Placebo once daily in the morning with food for year 1 then Cenicriviroc 150 mg tablet once daily in the morning with food for year 2
cenicriviroc CVC
CVC 150 mg, administered orally once daily and taken every morning with food
placebo PBO
Placebo administered orally once daily and taken every morning with food
(Placebo Comparator)
Placebo once daily in the morning with food for 2 years
placebo PBO
Placebo administered orally once daily and taken every morning with food

Primary Outcomes

Measure
Histological improvement in nonalcoholic fatty liver disease (NAFLD) activity score (NAS) score with no concurrent worsening of fibrosis stage (NASH CRN system)
time frame: Year 1

Secondary Outcomes

Measure
Complete resolution of steatohepatitis with no concurrent worsening of fibrosis stage
time frame: Year 1
Improvement in fibrosis by at least 1 stage (NASH CRN system) with no worsening of steatohepatitis
time frame: Years 1 and 2

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adult subjects aged between 18-75 - Histological evidence of NASH, based on biopsy, with a NAS of >= 4 with at least 1 in each component of NAS - Histological evidence of liver fibrosis defined as NASH CRN System Stage 1 to 3 - Meeting any of the 3 major criteria (a, b, c): 1. Documented evidence of type 2 diabetes mellitus 2. High body mass index (> 25 kg/m2) with at least one of the following criteria of metabolic syndrome, as defined by the National Cholesterol Education Program: - Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches (female) - Dyslipidemia: Triglycerides ≥ 1.7 mmol/L (150 mg/dL) - Dyslipidemia: High-density lipoprotein (HDL)-cholesterol < 40 mg/dL (male), < 50 mg/dL (female) - Blood pressure ≥ 130/85 mmHg (or currently being treated for hypertension) - Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dL) 3. Bridging fibrosis (NASH CRN Stage 3) and/or definite NASH (NAS ≥ 5) - Agree to have one liver biopsy at Screening, one at Year 1, and one at the end of study treatment (Year 2) - AST and ALT ≤ 5 × upper limit of normal (ULN) Exclusion Criteria: - Hepatitis B surface Antigen (HBsAg) positive - Hepatitis C antibody (HCVAb) positive with the following 2 exceptions: 1. Subjects previously treated for viral hepatitis C with at least a 1-year period since documented sustained virologic response at Week 12 (post-treatment) may be eligible if all other eligibility criteria are met 2. Subjects with presence of hepatitis C antibody but negative hepatitis C virus RNA without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met - Prior or planned liver transplantation - Other known causes of chronic liver disease, including alcoholic liver disease - History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding - Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer [285 mL], 1 glass of spirits [25 mL] or 1 glass of wine [125 mL]) - HIV-1 or HIV-2 infection - Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding) - Females who are pregnant or breastfeeding - Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements.

Additional Information

Official title CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Tobira Therapeutics, Inc..