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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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 13, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE February 8, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE norUrsodeoxycholic Acid vs Placebo in PSC
Official Title  ICMJE Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE Drug: norUrsodeoxycholic Acid
oral treatment
Other Name: NUC
Study Arms  ICMJE
  • Experimental: norUrsodeoxycholic acid
    norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
    Intervention: Drug: norUrsodeoxycholic Acid
  • Placebo Comparator: Placebo to norUrsodeoxycholic acid
    norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
    Intervention: Drug: norUrsodeoxycholic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2019)		 300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Markus Pröls, PhD ++49-761-1514 ext 0 zentrale@drfalkpharma.de
Contact: Michael Stiess, PhD ++49-761-1514 ext 0 zentrale@drfalkpharma.de
Listed Location Countries  ICMJE Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03872921
Other Study ID Numbers  ICMJE NUC-5/PSC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Current Responsible Party Dr. Falk Pharma GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dr. Falk Pharma GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Trauner, MD Medical University of Vienna, Department of Internal Medicine III
PRS Account Dr. Falk Pharma GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP