Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
NCT ID: NCT06886360
Last Updated: 2025-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2025-03-31
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis
NCT01755507
norUrsodeoxycholic Acid vs Placebo in PSC
NCT03872921
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
NCT02177136
Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis
NCT05866809
Norursodeoxycholic Acid vs. Placebo in NASH
NCT05083390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
norucholic acid 1500 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
norucholic acid
500 mg norucholic acid film-coated tablets; 3 tablets/day
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
norucholic acid
500 mg norucholic acid film-coated tablets; 3 tablets/day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Trauner, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, dept. of Internal Medicine III
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-514292-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
NUT-022/PSC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.