jRCT2080224728CompletedPhase 3
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
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences, K.K.
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Proportion of participants with progression of liver fibrosis at blinded phase week 96
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Randomized Controlled Study, Double Blind, Placebo Control, Paralle Assignment
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 18age old over to 75age old under (—)
- Sex
- All
Inclusion Criteria
- •Dignosis of large duct PSC
- •Liver biopsy at screening that is deemed acceptable for interpretation and demonstrates stage F0 - F3 fibrosis (according to the Ludwig classification) in the opinion of the central reader
- •Individual has the following laboratory parameters at the screening visit, as determined by the central laboratory:
- •a.Platelet count > =150,000/mm3
- •b.Estimated glomerular filtration rate (eGFR) > =30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
- •c.ALT <= 8 x upper limit of the normal range (ULN)
- •d.Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's syndrome or hemolytic anemia
- •e.International normalized ratio (INR) <= 1.4, unless due to therapeutic anticoagulation
- •f.Negative anti-mitochondrial antibody
Exclusion Criteria
- •Current or prior history of any of the following:
- •a.Cirrhosis
- •b.Liver transplantation
- •c.Cholangiocarcinoma or hepatocellular carcinoma (HCC)
- •d.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)
Outcomes
Primary Outcomes
Proportion of participants with progression of liver fibrosis at blinded phase week 96
Time Frame: week 96
Progression of liver fibrosis was defined as having a >=1-stage increase in fibrosis according to the Ludwig classification
Secondary Outcomes
- Changes from baseline in serum concentrations of ALP, ALT, and bile acids(Blinded Study Phase Week 96)
- Proportion of participants with >= 25% relative reduction in serum ALP concentration and no worsening of fibrosis(Blinded Study Phase Week 96)
- Proportion of participants with fibrosis improvement(Blinded Study Phase Week 96)
- Changes from baseline in noninvasive markers of fibrosis(Blinded Study Phase Week 96)
- Change from baseline in PSC Symptoms - Module 1(Blinded Study Phase Week 96)
Investigators
Study Sites (1)
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