Trials / Active Not Recruiting
Active Not RecruitingNCT03872921
norUrsodeoxycholic Acid vs Placebo in PSC
Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 303 (actual)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 16 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | norUrsodeoxycholic Acid | oral treatment |
Timeline
- Start date
- 2018-02-08
- Primary completion
- 2025-01-01
- Completion
- 2026-06-01
- First posted
- 2019-03-13
- Last updated
- 2024-08-06
Locations
2 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT03872921. Inclusion in this directory is not an endorsement.