NCT01755507

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2012

Typical duration for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

2.8 years

First QC Date

December 19, 2012

Last Update Submit

August 2, 2016

Conditions

Primary Sclerosing Cholangitis

Keywords

PSC

Outcome Measures

Primary Outcomes (1)

  • Change in serum AP levels during treatment

    12 weeks

Secondary Outcomes (1)

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

    12 weeks

Other Outcomes (1)

  • Adverse Events

    12 weeks

Study Arms (4)

B

EXPERIMENTAL

norUDCA

Drug: norUDCA

C

EXPERIMENTAL

norUDCA

Drug: norUDCA

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

A

EXPERIMENTAL

norUDCA

Drug: norUDCA

Interventions

norUDCADRUG

Comparison of different dosages of norUDCA acid administered orally.

ABC
PlaceboDRUG
placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prof. M. Trauner

Vienna, 1090, Austria

Location

Prof. Michael Manns

Hanover, 30623, Germany

Location

Kirsten Boberg

Oslo, 0424, Norway

Location

Related Publications (1)

  • 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.

    PMID: 28529147DERIVED

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Michael Trauner, Prof

    Med. Uni Wien

    PRINCIPAL INVESTIGATOR

  • Michael P Manns, Prof

    Med.Hochschule Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

AU(1)DE(1)NO(1)