Status:
NOT_YET_RECRUITING
Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06886360
Start Date
March 1 2025
End Date
September 1 2027
Last Update
March 20 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.