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

Primary Purpose

Primary Sclerosing Cholangitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
norUDCA
Placebo
Sponsored by
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring PSC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. M. Trauner
  • Prof. Michael Manns
  • Kirsten Boberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

B

C

placebo

A

Arm Description

norUDCA

norUDCA

Placebo

norUDCA

Outcomes

Primary Outcome Measures

Change in serum AP levels during treatment

Secondary Outcome Measures

Proportion of patients with at least 50% reduction in s-ALP

Full Information

First Posted
December 19, 2012
Last Updated
August 2, 2016
Sponsor
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01755507
Brief Title
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
Keywords
PSC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
norUDCA
Arm Title
C
Arm Type
Experimental
Arm Description
norUDCA
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A
Arm Type
Experimental
Arm Description
norUDCA
Intervention Type
Drug
Intervention Name(s)
norUDCA
Intervention Description
Comparison of different dosages of norUDCA acid administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in serum AP levels during treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with at least 50% reduction in s-ALP
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Trauner, Prof
Organizational Affiliation
Med. Uni Wien
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael P Manns, Prof
Organizational Affiliation
Med.Hochschule Hannover
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. M. Trauner
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Prof. Michael Manns
City
Hannover
ZIP/Postal Code
30623
Country
Germany
Facility Name
Kirsten Boberg
City
Oslo
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28529147
Citation
Fickert P, Hirschfield GM, Denk G, Marschall HU, Altorjay I, Farkkila M, Schramm C, Spengler U, Chapman R, Bergquist A, Schrumpf E, Nevens F, Trivedi P, Reiter FP, Tornai I, Halilbasic E, Greinwald R, Prols 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.
Results Reference
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Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

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