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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| norUrsodeoxycholic acid | Experimental | norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years |
|
| Placebo to norUrsodeoxycholic acid | Placebo Comparator | norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| norUrsodeoxycholic Acid | Drug | oral treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) | prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC | 2 years |
| Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) | prevention of disease progression assessed by liver histology | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Trauner, MD | Medical University of Vienna, Department of Internal Medicine III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna, Department of Internal Medicine III | Vienna | 1090 | Austria | |||
| Medical School Hannover |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38977324 | Derived | Li T, Chiang JYL. Bile Acid Signaling in Metabolic and Inflammatory Diseases and Drug Development. Pharmacol Rev. 2024 Oct 16;76(6):1221-1253. doi: 10.1124/pharmrev.124.000978. |
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It is not yet decided which data will be made available. Neither a time Frame can be indicated yet.
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C081331 | 24-norursodeoxycholic acid |
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| Hanover |
| Lower Saxonia |
| 30623 |
| Germany |