Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
303 participants
INTERVENTIONAL
2018-02-08
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
norUrsodeoxycholic Acid
oral treatment
Placebo to norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
norUrsodeoxycholic Acid
oral treatment
Interventions
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norUrsodeoxycholic Acid
oral treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* verified PSC
* Liver Biopsy available for Review
* If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw
* Patients with or without concomittant IBD
Exclusion Criteria
* Presence of Cholangiocarcinoma
* Secondary causes of Sclerosing Cholangitis
* Small Duct Cholangitis in the absence of large duct disease
* Any known relevant infectious disease
* Abnormal renal function
* Any active malignant disease
* Known intolerance/hypersensitivity to study drug
16 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Trauner, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Department of Internal Medicine III
Locations
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Medical University of Vienna, Department of Internal Medicine III
Vienna, , Austria
Medical School Hannover
Hanover, Lower Saxonia, Germany
Countries
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Other Identifiers
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NUC-5/PSC
Identifier Type: -
Identifier Source: org_study_id
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