norUrsodeoxycholic Acid vs Placebo in PSC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Vienna, Department of Internal Medicine III, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norUrsodeoxycholic Acid

Drug

oral treatment

Other names: NUC

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2025
Study completion: 2026
First posted: Mar 13, 2019
Registry last updated: Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting