Status:
ACTIVE_NOT_RECRUITING
norUrsodeoxycholic Acid vs Placebo in PSC
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief 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 serv...
Eligibility Criteria
Inclusion
- Signed informed consent
- 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
- History or presence of other concomitant liver diseases
- 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
Key Trial Info
Start Date :
February 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT03872921
Start Date
February 8 2018
End Date
June 1 2026
Last Update
August 6 2024
Active Locations (2)
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1
Medical University of Vienna, Department of Internal Medicine III
Vienna, Austria, 1090
2
Medical School Hannover
Hanover, Lower Saxonia, Germany, 30623