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

Trial ID or NCT#

NCT03890120

Status

recruiting iconRECRUITING

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: - 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 Key
Exclusion Criteria:
  1. - 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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Investigator(s)

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

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Contact

Tanvi Chitre
650-723-9651

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View on ClinicalTrials.gov