Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

Keywords

Primary Sclerosing Cholangitis Cholangitis Cholangitis, Sclerosing Cilofexor

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  • Diagnosis of large duct PSC
  • Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
  • Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
  • Platelet count ≥ 150,000/mm3

  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  • ALT ≤ 8 x upper limit of the normal range (ULN)
  • Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
  • International normalized ratio (INR) ≤ 1.4, unless due to therapeutic anticoagulation
  • Negative anti-mitochondrial antibody

Key Exclusion Criteria:

  • Current or prior history of any of the following:
  • Cirrhosis
  • Liver transplantation
  • Cholangiocarcinoma or hepatocellular carcinoma (HCC)
  • Ascending cholangitis within 30 days of screening
  • Presence of a percutaneous drain or biliary stent
  • Other causes of liver disease
  • Current or prior history of unstable cardiovascular disease
  • Current moderate to severely active inflammatory bowel disease (IBD)

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • University of California, Davis Medical Center (study visits) accepting new patients
    Sacramento California 95817 United States
  • University of California, San Francisco Liver Clinic accepting new patients
    San Francisco California 94143 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Related Info Sign up for this study
ID
NCT03890120
Phase
Phase 3
Study Type
Interventional
Last Updated