PiSCATIN - Simvastatin for the treatment of primary sclerosing cholangitis (PSC) - a randomized double-blind, placebo-controlled multicenter study
- Conditions
- Primary sclerosing cholangitis (PSC)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-511053-22-00
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 560
Patients with a cholangiographically verified PSC and/or liverbiopsy with and without IBD (patients with a present autoimmun hepatit and small duct PSC can be included), Men and women =18 years but =75 years, Patient has given written consent to participate in the study, MR/MRCP within 4 months, Coloscopy within 24 months if the patient has a known IBD, Female of childbearing potential must agree to use a highly efficient method of contraception during the study participation.
Patients on waiting list for transplantation, Transplanted patients, Patients with severe liver failure = Child B 9 points, Previous varices bleeding secondary to end stage liver disease, Previous cholangiocarcinoma, Patients with secondary sclerosing cholangitis, Patients who have been taking any statin medication during the last 3 months, Intolerance to statins, Pregnancy and breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method