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

Launched by DR. FALK PHARMA GMBH · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called norucholic acid, given in tablet form, for patients with a condition known as Primary Sclerosing Cholangitis (PSC). This trial is in the third phase, meaning it’s one of the final steps before the treatment can be approved for general use. The study aims to see how effective norucholic acid is in managing PSC symptoms and improving patients' health.

To participate, individuals need to be at least 18 years old and have a confirmed diagnosis of PSC. They should have either completed a previous related study or stopped participating in it due to lack of effectiveness. However, those with a history of heavy alcohol use, significant liver disease, or who have had a liver transplant are not eligible. The trial is still in the planning stages and hasn't started recruiting participants yet. If you qualify and choose to participate, you will take the medication and attend regular check-ups to monitor your health throughout the trial.

Gender

ALL

Eligibility criteria

• 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.