norUrsodeoxycholic Acid vs Placebo in PSC

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03872921
• Other study ID #: NUC-5/PSC
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

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