Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)



Status:Active, not recruiting
Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:4/6/2019
Start Date:March 21, 2018
End Date:October 2019

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

The primary objectives of this study are:

- To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674,
administered alone or in combination, in participants with bridging fibrosis or
compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH)

- To evaluate changes in liver fibrosis, without worsening of NASH


Key Inclusion Criteria:

- Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the
opinion of the central reader

- In participants who have never had a liver biopsy, liver stiffness by FibroScan® and
Enhanced Liver Fibrosis (ELF™) Test score at Screening

- Screening laboratory parameters, as determined by the central laboratory:

- Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the
Cockcroft-Gault equation

- HbA1c ≤ 9.5%

- Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)

- Platelet count ≥ 125,000/μL

Key Exclusion Criteria:

- Prior history of decompensated liver disease including ascites, hepatic
encephalopathy, or variceal bleeding

- Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as
Gilbert's syndrome or therapeutic anticoagulation

- Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an
alternate etiology such as therapeutic anticoagulation

- Other causes of liver disease based on medical history and/or centralized review of
liver histology, including but not limited to: alcoholic liver disease, hepatitis B,
hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing
cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,
clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring
treatment

- History of liver transplantation

- Current or prior history of hepatocellular carcinoma

Note: Other protocol defined Inclusion/ Exclusion criteria may apply
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