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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03872921
Other study ID # NUC-5/PSC
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 8, 2018
Est. completion date December 2023

Study information

Verified date October 2019
Source Dr. Falk Pharma GmbH
Contact Markus Pröls, PhD
Phone ++49-761-1514
Email zentrale@drfalkpharma.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
norUrsodeoxycholic Acid
oral treatment

Locations

Country Name City State
Austria Medical University of Vienna, Department of Internal Medicine III Vienna
Germany Medical School Hannover Hannover Lower Saxonia

Sponsors (1)

Lead Sponsor Collaborator
Dr. Falk Pharma GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
Primary 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 2 years
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