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

• Status: Completed
• Trial end date: 2017-06-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tobira Therapeutics, Inc.
• Treatments: Cenicriviroc; TAK-652

Criteria

Inclusion Criteria:

• Adult participants aged between 18-75

• Histological evidence of NASH, based on biopsy, with a Nonalcoholic fatty liver disease Activity Score (NAS) of >= 4 with at least 1 in each component of NAS

• Histological evidence of liver fibrosis defined as NASH Clinical Research Network (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/m^2) 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)

• Aspartate aminotransferase (AST) and alanine aminotransferase (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. Participants 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. Participants with presence of hepatitis C antibody but negative hepatitis C virus ribonucleic acid 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])

• Human immunodeficiency virus (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 participant unsuitable for the study or unable to comply with the dosing and protocol requirements.