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Study of Cilofexor in Adults With Primary Sclerosing Cholangitis

NCT03890120 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2023-11-29

Study results available
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Summary

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).

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

Cilofexor

100 mg tablet administered orally once daily

DRUG

Placebo

Tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2022-11-10
Completion
2022-12-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • New Zealand
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890120 on ClinicalTrials.gov