Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

  • Interventional
  • Not Recruiting
  • NCT03053063
Eligibility Details Visit Clinicaltrials.gov

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)

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

Gender
All

Age Group
18 Years to 70 Years

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader

         - Has the following laboratory parameters at the screening visit, as determined by the central laboratory:

             - Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

             - Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation

             - HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)

        Key Exclusion Criteria:

         - Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding

         - Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation

         - Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation

         - Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/or centralized review of liver histology.

         - History of liver transplantation

         - Current or history of hepatocellular carcinoma (HCC)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
  • Nonalcoholic Steatohepatitis (NASH)

At a Glance

National Government IDNCT03053063

IRB#IRB17-0434

Lead SponsorGilead Sciences

Lead PhysicianHelen S. Te

Collaborator(s)N/A

EligibilityAll
18 Years to 70 Years
Not Recruiting