Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)

August 2, 2016 updated by: Dr. Falk Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Prof. M. Trauner
  • Germany
      • Hannover, Germany, 30623
        • Prof. Michael Manns
  • Norway
      • Oslo, Norway, 0424
        • Kirsten Boberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum AP levels during treatment
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Michael Trauner, Prof, Med. Uni Wien
  • Principal Investigator: Michael P Manns, Prof, Med.Hochschule Hannover

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUC-3/PSC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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