Back to resultsnorUrsodeoxycholic Acid vs Placebo in PSC
Primary Purpose
Primary Sclerosing Cholangitis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
norUrsodeoxycholic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of Internal Medicine IIIRecruiting
- Medical School HannoverRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
norUrsodeoxycholic acid
Placebo to norUrsodeoxycholic acid
Arm Description
norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03872921
Brief Title
norUrsodeoxycholic Acid vs Placebo in PSC
Official Title
Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
norUrsodeoxycholic acid
Arm Type
Experimental
Arm Description
norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
Arm Title
Placebo to norUrsodeoxycholic acid
Arm Type
Placebo Comparator
Arm Description
norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
Intervention Type
Drug
Intervention Name(s)
norUrsodeoxycholic Acid
Other Intervention Name(s)
NUC
Intervention Description
oral treatment
Primary Outcome Measure Information:
Title
superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
Description
prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC
Time Frame
2 years
Title
Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
Description
prevention of disease progression assessed by liver histology
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Pröls, PhD
Phone
++49-761-1514
Ext
0
Email
zentrale@drfalkpharma.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Stiess, PhD
Phone
++49-761-1514
Ext
0
Email
zentrale@drfalkpharma.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Trauner, MD
Organizational Affiliation
Medical University of Vienna, Department of Internal Medicine III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Internal Medicine III
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Trauner, MD
Phone
0043 (0)1 40400
Ext
47440
Email
michael.trauner@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Emina Halilbasic, MD
Phone
0043 (0)1 40400
Ext
491210
Email
emina.halilbasic@meduniwien.ac.at
Facility Name
Medical School Hannover
City
Hannover
State/Province
Lower Saxonia
ZIP/Postal Code
30623
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heike Bantel, MD
Phone
+49 511 532
Ext
9514
Email
bantel.heike@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Markus Cornberg, MD
Phone
+49 511 532
Ext
6821
Email
cornberg.markus@mh-hannover.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet decided which data will be made available. Neither a time Frame can be indicated yet.
Learn more about this trial
norUrsodeoxycholic Acid vs Placebo in PSC
We'll reach out to this number within 24 hrs