Clinical Trial

norUrsodeoxycholic Acid vs Placebo in PSC

Active, Not Recruiting Phase 3
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Record status
This record was last updated August 6, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-03-11; most recent amendment 2024-08-05.
Status change: Recruiting → Active, Not Recruiting 2024-08-05
Trial Details
NCT Number NCT03872921
Lead Sponsor Dr. Falk Pharma GmbH
Conditions Primary Sclerosing Cholangitis
Enrollment 303 participants
Start Date 2018-02-08
Primary Completion 2025-01 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2024-08-06