Primary Sclerosing Cholangitis
Conditions
Brief summary
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Interventions
DRUGnorucholic acid
500 mg norucholic acid film-coated tablets; 3 tablets/day
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of treatment emergent adverse events | 72 weeks from enrollment to end of treatment |
| Occurrence of serious treatment emergent adverse events | 72 weeks from enrollment to end of treatment |
| Occurrence of severe treatment emergent adverse events | 72 weeks from enrollment to end of treatment |
| Occurrence of adverse drug reactions | 72 weeks from enrollment to end of treatment |
| Occurrence of unexpected treatment emergent adverse events | 72 weeks from enrollment to end of treatment |
| Occurrence of treatment emergent adverse events leading to study withdrawal | 72 weeks from enrollment to end of treatment |
| Occurrence of adverse events leading to death | 72 weeks from enrollment to end of treatment |
Contacts
Primary ContactMichael Stiess, PhD
Outcome results
None listed