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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cilofexor
Cilofexor for 96 weeks
  • Drug: Cilofexor
    100 mg tablet administered orally once daily
    Other names:
    • GS-9674
Placebo Comparator
Placebo
Placebo for 96 weeks
  • Drug: Placebo
    Tablet administered orally once daily

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467

More Details

NCT ID
NCT03890120
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.