norUrsodeoxycholic Acid vs Placebo in PSC

August 5, 2024 updated by: Dr. Falk Pharma GmbH

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Internal Medicine III
  • Germany
    • Lower Saxonia
      • Hannover, Lower Saxonia, Germany, 30623
        • Medical School Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
Drug: norUrsodeoxycholic Acid
oral treatment
Other Names:
  • NUC
Placebo Comparator: Placebo to norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
Drug: norUrsodeoxycholic Acid
oral treatment
Other Names:
  • NUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
Time Frame: 2 years
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)
Time Frame: 2 years
prevention of disease progression assessed by liver histology
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Michael Trauner, MD, Medical University of Vienna, Department of Internal Medicine III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 8, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUC-5/PSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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