norUrsodeoxycholic Acid vs Placebo in PSC
Phase 3
Active, not recruiting
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Registration Number
- NCT03872921
- Lead Sponsor
- Dr. Falk Pharma GmbH
- 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 serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 303
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo to norUrsodeoxycholic acid norUrsodeoxycholic Acid norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years norUrsodeoxycholic acid norUrsodeoxycholic Acid norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
- Primary Outcome Measures
Name Time Method superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) 2 years prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC
Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) 2 years prevention of disease progression assessed by liver histology
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Medical School Hannover
🇩🇪Hannover, Lower Saxonia, Germany
Medical University of Vienna, Department of Internal Medicine III
🇦🇹Vienna, Austria