Norursodeoxycholic Acid in the Treatment of Primary Scler... | NCT01755507

Studies
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

NCT01755507

Sponsor

Dr. Falk Pharma GmbH

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

159Actual

Phase

Phase 2

Conditions

Primary Sclerosing Cholangitis

Interventions

norUDCA
Placebo

Countries

Austria
Germany
Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 19, 2012

First Submission Date that Met QC Criteria

Dec 21, 2012

First Posted Date

Dec 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B	Experimental	norUDCA	Drug: norUDCA
C	Experimental	norUDCA	Drug: norUDCA
placebo	Placebo Comparator	Placebo	Drug: Placebo
A	Experimental	norUDCA	Drug: norUDCA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
norUDCA	Drug	Comparison of different dosages of norUDCA acid administered orally.	A B C

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Adverse Events		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Trauner, Prof	Med. Uni Wien	Principal Investigator
Michael P Manns, Prof	Med.Hochschule Hannover	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. M. Trauner		Vienna		1090	Austria
Prof. Michael Manns

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28529147	Derived	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.

ID	Term
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases