A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
ID Number 17-0669Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to evaluate whether selonsertib (SEL, previously known as GS-4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH and to assess the safety and tolerability of SEL in subjects with Nonalcoholic Steatohepatitis (NASH) and cirrhosis.
Subject participation in this study is expected to last 252 weeks, which includes an 8-week Screening period, a 240-week treatment period and a 4-week follow-up period.
This is a randomized, double-blind, placebo-controlled study. Subjects cannot choose which group they are in. If subjects agree to take part in this study and meet all of the requirements, they will be randomized to one of the following three study treatment groups:
- Group A: 240 weeks of selonsertib 6 mg tablet + placebo 18 mg tablet once daily
- Group B: 240 weeks of selonsertib 18 mg tablet + placebo 6 mg tablet once daily
- Group C: 240 weeks of placebo 6 mg tablet + placebo 18 mg tablet once daily
The total number of people expected to take part in this research study is approximately 800. This study will take place at about 400 sites worldwide. This study is open to male and female subjects, 18 to 70 years of age, who meet the study requirements.
Recruiting Patients: Yes