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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dr. Falk Pharma GmbH

ClinicalTrials.gov Identifier:

NCT01755507

First received: December 19, 2012

Last updated: August 2, 2016

Last verified: August 2016

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, 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:

Genetics Home Reference related topics: primary sclerosing cholangitis

Genetic and Rare Diseases Information Center resources: Primary Sclerosing Cholangitis

U.S. FDA Resources

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

Primary Outcome Measures:

Change in serum AP levels during treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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

Other Outcome Measures:

Adverse Events [ Time Frame: 12 weeks ]


Enrollment:	159
Study Start Date:	December 2012
Study Completion Date:	December 2015
Primary Completion Date:	October 2015 (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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent
Verified diagnosis of PSC
PSC patients with or without IBD
Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion Criteria:

History or presence of other concomitant liver diseases
Treatment with UDCA within 8 weeks prior to baseline visit.
Child B/C liver cirrhosis
Total bilirubin > 3.0 mg/dl at screening or baseline.
Any relevant systemic disease
TSH>ULN at screening
any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
Any active malignant disease
Known intolerance/hypersensitivity to study drug
Existing or intended pregnancy of brest feeding
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

Locations


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


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:	August 2, 2016

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 June 23, 2017

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