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Norursodeoxycholic Acid vs Placebo in PSC

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ClinicalTrials.gov Identifier: NCT03872921
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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: Norursocholic Acid Phase 3

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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


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

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




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



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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

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
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Contact: Markus Pröls, PhD *49-761-15-14 ext 199 proels@drfalkpharma.de
Contact: Michael Stiess, PhD *49-761-15-14 ext 261 stiess@drfalkpharma.de

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

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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT03872921     History of Changes
Other Study ID Numbers: NUC-5/PSC
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 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.

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