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

• Status: Terminated
• Trial end date: 2019-05-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Selonsertib

Criteria

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 micromole (μmol) if HbA1c is unable to be resulted)

• International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation

• Platelet count ≥ 100,000/μL

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-antitrypsin 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.