Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

Trial ID or NCT#

NCT03890120

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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
    1. Key
Exclusion Criteria:
  1. * Current or prior history of any of the following:
  2. * 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)
    1. Note: Other protocol defined Inclusion/Exclusion criteria may apply
View All Criteria
Show Less

Investigator(s)

Aparna Goel
Hepatologist, Transplant hepatologist
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology

Contact us to find out if this trial is right for you.

Contact

Tanvi Chitre
650-723-9651

View on ClinicalTrials.gov