Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tobira Therapeutics, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
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)
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.
You may not be if
Hepatitis B surface Antigen (HBsAg) positive
Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:
Clareo Health | Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
