Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH

Criteria

Inclusion Criteria:

1. Signed Informed Consent

2. Verified diagnosis of PSC

3. PSC patients with or without IBD

4. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion Criteria:

1. History or presence of other concomitant liver diseases

2. Treatment with UDCA within 8 weeks prior to baseline visit.

3. Child B/C liver cirrhosis

4. Total bilirubin > 3.0 mg/dl at screening or baseline.

5. Any relevant systemic disease

6. TSH>ULN at screening

7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder

8. Any active malignant disease

9. Known intolerance/hypersensitivity to study drug

10. Existing or intended pregnancy of brest feeding

11. Simultaneous participation in another clinical trial