Phase III
Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis (PRIMIS)
- Study HIC#:2000025197
- Last Updated:07/15/2021
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).
- Age18 years - 75 years
- GenderBoth
- Start Date02/19/2020
- End Date08/31/2023
Trial Purpose and Description
To evaluate whether GS-9674 reduces the risk of fibrosis progression among non-cirrhotic
subjects with PSC
Eligibility Criteria
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
- 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 severely active inflammatory bowel disease (IBD)
Note: Other protocol defined Inclusion/Exclusion criteria may apply