Safety Tolerability and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    400
  • sponsor
    Gilead Sciences
Updated on 25 July 2021
Investigator
Gilead Study Team
Primary Contact
Osaka University Hospital (5.6 mi away) Contact
+231 other location
platelet count
fibrosis
cilofexor

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).

Details
Condition Primary Sclerosing Cholangitis
Treatment Placebo, Cilofexor
Clinical Study IdentifierNCT03890120
SponsorGilead Sciences
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

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/mm^3
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

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 severe inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, and indeterminate colitis)
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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