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Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC) | Clinical Trials | Clareo Health

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Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets

NCT06886360•Dr. Falk Pharma GmbH

View on ClinicalTrials.gov

Summary

Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent.
•2. Males or females ≥ 18 years.
•3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\*. (\*Lack of efficacy as defined in the NUC-5/PSC trial.)

Exclusion Criteria

•1. History or presence of chronic alcoholic consumption (daily consumption \> 30 g in men, \> 20 g in women).
•2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
•3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.
•4. History of liver transplantation or patient listed for transplantation.

Key Dates

Start Date

March 1, 2025

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

March 20, 2025

Enrollment

120

ESTIMATED participants

Conditions

Primary Sclerosing Cholangitis

Interventions

norucholic acid

DRUG

Contacts

Michael Stiess, PhD

CONTACT

+497611514 Ext. 0 zentrale@drfalkpharma.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Inclusion Criteria

Exclusion Criteria

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