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 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


drug: Cilofexor

drug: Placebo

Not Recruiting

Contact Information

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