CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis
CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis
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.
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):
Documented evidence of type 2 diabetes mellitus
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:
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:
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.