Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Lead Sponsor:
Gilead Sciences
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants w...
Eligibility Criteria
Inclusion
- Key
- Liver biopsy consistent with NASH and F3 or F4 in the opinion of the central reader
- In participants who have never had a liver biopsy, liver stiffness by FibroScan® ≥ 14.0 kPa and Enhanced Liver Fibrosis (ELF™) Test score ≥ 9.8 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
- Hemoglobin A1c (HbA1c) ≤ 9.5%
- Alanine aminotransferase (ALT) \< 5 x Upper Limits of Normal (ULN)
- Platelet count ≥ 125,000/μL
- Key
Exclusion
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT03449446
Start Date
March 21 2018
End Date
November 19 2019
Last Update
December 3 2020
Active Locations (101)
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1
The Institute for Liver Health
Chandler, Arizona, United States, 85224-5688
2
Mayo Clinic Arizona, Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
3
Liver Wellness Center
Little Rock, Arkansas, United States, 72204
4
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117