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norUrsodeoxycholic Acid vs Placebo in PSC
Sponsor: Dr. Falk Pharma GmbH
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.
Official title: Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
Key Details
Gender
All
Age Range
16 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
303
Start Date
2018-02-08
Completion Date
2026-06
Last Updated
2024-08-06
Healthy Volunteers
No
Conditions
Interventions
norUrsodeoxycholic Acid
oral treatment
Locations (2)
Medical University of Vienna, Department of Internal Medicine III
Vienna, Austria
Medical School Hannover
Hanover, Lower Saxonia, Germany