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

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ClinicalTrials.gov Identifier: NCT01755507

Recruitment Status : Completed

First Posted : December 24, 2012

Last Update Posted : August 3, 2016

Sponsor:

Information provided by (Responsible Party):

Dr. Falk Pharma GmbH

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Primary Sclerosing Cholangitis	Drug: norUDCA Drug: Placebo	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	159 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (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
Study Start Date :	December 2012
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	December 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Primary sclerosing cholangitis

Genetic and Rare Diseases Information Center resources: Primary Sclerosing Cholangitis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755507

Locations

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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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fickert P, Hirschfield GM, Denk G, Marschall HU, Altorjay I, Färkkilä M, Schramm C, Spengler U, Chapman R, Bergquist A, Schrumpf E, Nevens F, Trivedi P, Reiter FP, Tornai I, Halilbasic E, Greinwald R, Pröls M, Manns MP, Trauner M; European PSC norUDCA Study Group. norUrsodeoxycholic acid improves cholestasis in primary sclerosing cholangitis. J Hepatol. 2017 Sep;67(3):549-558. doi: 10.1016/j.jhep.2017.05.009. Epub 2017 May 18.

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Responsible Party:	Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:	NCT01755507 History of Changes
Other Study ID Numbers:	NUC-3/PSC
First Posted:	December 24, 2012 Key Record Dates
Last Update Posted:	August 3, 2016
Last Verified:	August 2016

Keywords provided by Dr. Falk Pharma GmbH:


PSC

Additional relevant MeSH terms:

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Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

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