Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

Not Recruiting

Trial ID: NCT03890120


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

Stanford Investigator(s)

Aparna Goel

Clinical Associate Professor, Medicine - Gastroenterology & Hepatology


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/mm^3

      - Estimated glomerular filtration rate (eGFR) ≥ 30 milliliter/minute (mL/min), as
      calculated by the Cockcroft-Gault equation

      - Alanine transaminase (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

      - 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 severe inflammatory bowel disease (IBD) (including ulcerative
   colitis, Crohn's disease, and indeterminate colitis)

Note: Other protocol defined Inclusion/Exclusion criteria may apply


drug: Cilofexor

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tanvi Chitre