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