Primary Sclerosing Cholangitis (PSC)
Conditions
Interventions
One group is receiving once daily 1500 mg norursorsodeoxycholic acid (= 6
capsules) and the other group is receiving once daily a placebo (= 6 capsules).
OLE phase: All patients will receive Norursod
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent 2. Males or Females 3. Verified PSC 4. Liver Biopsy available 8. Women of child-bearing potential who are sexually active have to apply a highly effective method of brith control For open-label extension (OLE) phase: 1. Signed Informed Consent 2. DBE phase completed with Visit 22
Exclusion criteria
Exclusion criteria: 1. History or presence of other concomitant liver diseases 4. Secondary causes of Sclerosing Cholangitis 11. Total bilirubin > 4.0 mg/dl (>68 µmol/L) at screening or baseline 13. Any relevant infectious disease (e.g. AIDS) 14. Abnormal renal function 15. Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable if fT4 is measured and within the normal range) 17. Any active malignant disease 18. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile 19. Well-founded doubt about the patient's cooperation 20. Existing or intented pregnancy or breast-feeding 21. Participation in another clinical trial within the last 30 days
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Key secondary efficacy endpoint: • Partial normalization of s-ALP to | — |
Primary
| Measure | Time frame |
|---|---|
| Partial normalization of s-ALP to = 1.5x ULN at week 96. If no value at week 96 exists, the s-ALP criterion is *no*. 2) Histological criterion: yes = no worsening of the Ludwig stage; no = otherwise or if no Ludwig stage is available at week 96. The primary endpoint is: - Yes = if both criteria above are *yes*. - No = otherwise. | — |
Countries
Netherlands
Outcome results
None listed