Education and Training

Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

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).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Cilofexor
  • drug: Placebo

Eligibility


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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tanvi Chitre
650-723-9651
Not Recruiting