Safety and Efficacy of Selonsertib in Adults With 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 - 70
Updated:3/7/2019
Start Date:January 30, 2017
End Date:April 2019

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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.


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.
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