Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

norUrsodeoxycholic Acid vs Placebo in PSC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03872921
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: norUrsodeoxycholic Acid Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872921


Contacts
Layout table for location contacts
Contact: Markus Pröls, PhD ++49-761-1514 ext 0 zentrale@drfalkpharma.de
Contact: Michael Stiess, PhD ++49-761-1514 ext 0 zentrale@drfalkpharma.de

Locations
Layout table for location information
Austria
Medical University of Vienna, Department of Internal Medicine III Recruiting
Vienna, Austria, 1090
Contact: Michael Trauner, MD    0043 (0)1 40400 ext 47440    michael.trauner@meduniwien.ac.at   
Contact: Emina Halilbasic, MD    0043 (0)1 40400 ext 491210    emina.halilbasic@meduniwien.ac.at   
Germany
Medical School Hannover Recruiting
Hannover, Lower Saxonia, Germany, 30623
Contact: Heike Bantel, MD    +49 511 532 ext 9514    bantel.heike@mh-hannover.de   
Contact: Markus Cornberg, MD    +49 511 532 ext 6821    cornberg.markus@mh-hannover.de   
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Layout table for investigator information
Principal Investigator: Michael Trauner, MD Medical University of Vienna, Department of Internal Medicine III
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT03872921    
Other Study ID Numbers: NUC-5/PSC
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not yet decided which data will be made available. Neither a time Frame can be indicated yet.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases