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Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Not Recruiting
Trial ID: NCT03890120
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
Stanford Investigator(s)
Aparna Goel
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology
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
Intervention(s):
drug: Cilofexor
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tanvi Chitre
650-723-9651