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Summary

for people ages 18–70 (full criteria)
at San Francisco, 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

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 Francisco (UCSF) accepting new patients
    San Francisco, California, 94143, United States
  • California Pacific Medical Center accepting new patients
    San Francisco, California, 94115, United States
  • Mission Gastroenterology and Hepatology accepting new patients
    San Francisco, California, 94115, United States
  • Fresno Clinical Research Center accepting new patients
    Fresno, California, 93720, United States
  • Silicon Valley Research Institute accepting new patients
    San Jose, California, 95128, United States
  • University of California Davis accepting new patients
    Sacramento, California, 95817, United States
  • VA Greater Los Angeles Healthcare System accepting new patients
    Sacramento, California, 95817, United States
  • Island View Gastroenterology Associates- Ventura accepting new patients
    Ventura, California, 93003, United States
  • Cedars Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Ruane Clinical Research Group accepting new patients
    Los Angeles, California, 90036, United States
  • Gastrointestinal Biosciences accepting new patients
    Los Angeles, California, 90067, United States
  • California Liver Institute accepting new patients
    Pasadena, California, 91105, United States
  • Huntington Medical Research Institutes accepting new patients
    Pasadena, California, 91105, United States
  • VA Greater Los Angeles Healthcare System accepting new patients
    Los Angeles, California, 90073, United States
  • Inland Empire Liver Foundation accepting new patients
    San Bernardino, California, 92377, United States
  • Kindred Medical Institute for Clinical Trials, LLC accepting new patients
    Corona, California, 92879, United States
  • Kaiser Permanente accepting new patients
    San Diego, California, 92514, United States
  • United Gastroenterologists accepting new patients
    Costa Mesa, California, 92626, United States
  • WCCT Global, LLC accepting new patients
    Costa Mesa, California, 92626, United States
  • Southern California Liver Centers accepting new patients
    Coronado, California, 92673, United States
  • eStudySite accepting new patients
    Las Vegas, Nevada, 89109, United States
  • eStudySite accepting new patients
    Oceanside, California, 92056, United States
  • Kaiser Permanente accepting new patients
    San Marcos, California, 92078, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03053050
Phase
Phase 3
Study Type
Interventional
Last Updated
November 16, 2017
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