NCT03872921

Brief Summary

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

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

February 8, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

6.9 years

First QC Date

March 8, 2019

Last Update Submit

August 5, 2024

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (2)

  • superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)

    prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC

    2 years

  • Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)

    prevention of disease progression assessed by liver histology

    2 years

Study Arms (2)

norUrsodeoxycholic acid

EXPERIMENTAL

norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years

Drug: norUrsodeoxycholic Acid

Placebo to norUrsodeoxycholic acid

PLACEBO COMPARATOR

norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years

Drug: norUrsodeoxycholic Acid

Interventions

norUrsodeoxycholic AcidDRUG

oral treatment

Also known as: NUC
Placebo to norUrsodeoxycholic acidnorUrsodeoxycholic acid

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • verified PSC
  • Liver Biopsy available for Review
  • If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw
  • Patients with or without concomittant IBD

You may not qualify if:

  • History or presence of other concomitant liver diseases
  • Presence of Cholangiocarcinoma
  • Secondary causes of Sclerosing Cholangitis
  • Small Duct Cholangitis in the absence of large duct disease
  • Any known relevant infectious disease
  • Abnormal renal function
  • Any active malignant disease
  • Known intolerance/hypersensitivity to study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of Vienna, Department of Internal Medicine III

Vienna, 1090, Austria

Location

Medical School Hannover

Hanover, Lower Saxonia, 30623, Germany

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Interventions

24-norursodeoxycholic acid

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Michael Trauner, MD

    Medical University of Vienna, Department of Internal Medicine III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 13, 2019

Study Start

February 8, 2018

Primary Completion

January 1, 2025

Study Completion

June 1, 2026

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

It is not yet decided which data will be made available. Neither a time Frame can be indicated yet.

Locations

DE(1)AU(1)