Summary

for people ages 18-70 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Keywords

Nonalcoholic Steatohepatitis Fatty Liver Non-alcoholic Fatty Liver Disease SEL SEL 6 mg SEL 18 mg

Eligibility

For people ages 18-70

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH CRN classification in the opinion of the central reader
  • Has the following laboratory parameters at the screening visit:
  • 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
  • Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
  • Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 6, 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.

Locations

  • University of California San Diego (UCSD)
    La Jolla California 92103 United States
  • Medical Associates Research Group
    San Diego California 92123 United States
  • Kaiser Permanente
    San Diego California 92514 United States
  • TriWest Research Associates, LLC
    El Cajon California 92020 United States
  • eStudySite
    Chula Vista California 91911 United States
  • eStudySite
    Oceanside California 92056 United States
  • Southern California Liver Centers
    Coronado California 92673 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03053050
Phase
Phase 3
Study Type
Interventional
Last Updated
May 11, 2018