Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Study Overview
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Brief Summary
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Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.

Detailed Description
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Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.

Official Title
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Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

Conditions
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Primary Sclerosing Cholangitis

Intervention / Treatment
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* Drug: norUDCA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Verified diagnosis of PSC PSC patients with or without IBD Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control. Exclusion Criteria: History or presence of other concomitant liver diseases Treatment with UDCA within 8 weeks prior to baseline visit. Child B/C liver cirrhosis Total bilirubin > 3.0 mg/dl at screening or baseline. Any relevant systemic disease TSH>ULN at screening any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder Any active malignant disease Known intolerance/hypersensitivity to study drug Existing or intended pregnancy of brest feeding Simultaneous participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>norUDCA | Drug: norUDCA<br>* Comparison of different dosages of norUDCA acid administered orally.<br>|
| Experimental: C<br>norUDCA | Drug: norUDCA<br>* Comparison of different dosages of norUDCA acid administered orally.<br>|
| Placebo Comparator: placebo<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: A<br>norUDCA | Drug: norUDCA<br>* Comparison of different dosages of norUDCA acid administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum AP levels during treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with at least 50% reduction in s-ALP |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSC