Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
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.)
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.
Single group
norucholic acid
Drug500 mg norucholic acid film-coated tablets; 3 tablets/day
Occurrence of treatment emergent adverse events
Occurrence of serious treatment emergent adverse events
Occurrence of severe treatment emergent adverse events
Occurrence of adverse drug reactions
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This trial is not recruiting at the moment. You can still explore other options:
