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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Dr. Falk Pharma GmbH
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01755507
First received: December 19, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: norUDCA
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • Change in serum AP levels during treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with at least 50% reduction in s-ALP [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: placebo
Placebo
Drug: Placebo
Experimental: A
norUDCA
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755507

Contacts
Contact: Markus Proels, PhD +49-7611514 ext 199 proels@drfalkpharma.de

Locations
Austria
Prof. M. Trauner Recruiting
Wien, Austria, 1090
Germany
Prof. Michael Manns Recruiting
Hannover, Germany, 30623
Norway
Kirsten Boberg Recruiting
Oslo, Norway, 0424
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Principal Investigator: Michael Trauner, Prof Med. Uni Wien
Principal Investigator: Michael P Manns, Prof Med. Hochschule Hannover
  More Information

No publications provided

Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01755507     History of Changes
Other Study ID Numbers: NUC-3/PSC
Study First Received: December 19, 2012
Last Updated: September 25, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency

Keywords provided by Dr. Falk Pharma GmbH:
PSC

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014