Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

— NUC-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755507
• Other study ID #: NUC-3/PSC
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2012
• Last updated: August 2, 2016
• Start date: December 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices AgencyGermany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Drug:
• norUDCA
Comparison of different dosages of norUDCA acid administered orally.
• Placebo

Locations

Country	Name	City	State
Austria	Prof. M. Trauner	Wien
Germany	Prof. Michael Manns	Hannover
Norway	Kirsten Boberg	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events		12 weeks	Yes
Primary	Change in serum AP levels during treatment		12 weeks	No
Secondary	Proportion of patients with at least 50% reduction in s-ALP		12 weeks	No