Western States Clinical Research, Inc. & the doctors of Rocky Mountain Gastroenterology are conducting research trials investigating medications for treatment in patients with Nonalcoholic Steatohepatitis (NASH) and bridging fibrosis. If you, or someone you know, may be interested in learning more about this research study, or another study for patients with NASH; please contact us with your interest.
Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib (the study medication) in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Study Purpose/Objective: The purpose of this study is to evaluate whether the study drug (selonsertib) can cause fibrosis regression. The primary objective is to prevent progression of cirrhosis and associated complications in subjects with NASH (nonalcoholic steatohepatitis) and bridging (F3) fibrosis.
Eligible study participants will : – Be between the ages of 18-70 years’ old
– If a male or female of reproductive age/childbearing potential: Be willing to use contraception (birth control) throughout study participation & not planning pregnancy and/or not a currently pregnant or currently lactating female
– Have a diagnosis of NASH with bridging (F3) Fibrosis as evident by a liver biopsy obtained during study screening or a historical biopsy within the past 6 months of the study screening visit.
– Not have another cause of liver disease, such as: alcoholic liver disease, hepatitis B, hepatitis C, liver disease caused by an autoimmune disorder, or drug-induced hepatoxicity.
– Not have had a liver transplant
– Not have a history of cancer in the past 5 years (with the exception of adequately treated cervical CIS & select skin cancers)
– Not have an unstable heart condition
Study Duration: Participation in the study can last up to 252 weeks, which includes an 8-week Screening period, a 240-week treatment period and a 4-week follow-up period
Study Medication/Investigational Product: Eligible study participants will be randomly assigned treatment of SEL 6 mg, SEL 18 mg or placebo (an inactive substance), in a double-blind manner (neither the study volunteer nor the research staff or physicians will know the assignment). The ratio of treatment arms to placebo will be 2:2:1. The study medication is a tablet to be taken by mouth and swallowed once daily.
Study Procedures: Include physical exams with the study doctors, laboratory assessments, a liver biopsy is required if study participant has not had an acceptable liver biopsy within the past 6 months to study screening and at 2 visits during the study treatment period, pregnancy tests, ECGs, and health related questionnaires will also be completed.
Stipend: A stipend will be provided to qualified study participants to help defray time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form. Note: There is no stipend for a Pre-study visit, if such a visit is scheduled.