Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06886360

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent.
  • Males or females ≥ 18 years.
  • 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

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

Treatment and study plan

norucholic acid

Drug

500 mg norucholic acid film-coated tablets; 3 tablets/day

Primary outcomes

  1. Occurrence of treatment emergent adverse events

    Time frame: 72 weeks from enrollment to end of treatment

  2. Occurrence of serious treatment emergent adverse events

    Time frame: 72 weeks from enrollment to end of treatment

  3. Occurrence of severe treatment emergent adverse events

    Time frame: 72 weeks from enrollment to end of treatment

  4. Occurrence of adverse drug reactions

    Time frame: 72 weeks from enrollment to end of treatment

  5. Occurrence of unexpected treatment emergent adverse events

    Time frame: 72 weeks from enrollment to end of treatment

  6. Occurrence of treatment emergent adverse events leading to study withdrawal

    Time frame: 72 weeks from enrollment to end of treatment

  7. Occurrence of adverse events leading to death

    Time frame: 72 weeks from enrollment to end of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Stiess, PhD

CONTACT

[email protected]

+497611514 Ext. 0

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

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.

Related clinical trials

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