Status:
ACTIVE_NOT_RECRUITING
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Lead Sponsor:
Annika Bergquist
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough The study will include...
Detailed Description
Please see published protocol Long Term Effect of Simvastatin in Primary Sclerosing Cholangitits: A Placebo-Controlled, Double-Blind, Multicenter Phase III Study (Piscatin) A. Bergquist, H. U. Marsc...
Eligibility Criteria
Inclusion
- PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD).
- Men and women between ≥18 years and ≤75 years.
- Written informed consent.
- A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization.
- Colonoscopy performed within 24 months prior to randomization, if known IBD.
- For women of childbearing potential efficient contraceptive.
Exclusion
- Subjects on waiting list for transplantation
- Transplanted subjects
- Previous variceal bleeding
- Previous hepatobiliary malignancy
- Subjects with secondary sclerosing cholangitis
- Intake of any type of statins within 3 months prior to randmization
- Known intolerance to simvastatin.
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2030
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT04133792
Start Date
October 1 2020
End Date
March 31 2030
Last Update
September 5 2025
Active Locations (12)
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1
Skåne Universitetssjukhus
Malmo, Skåne County, Sweden, 222 42
2
Norrlands Universitetssjukhus
Umeå, Västerbotten County, Sweden, 907 37
3
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden, 413 45
4
Sahlgrenska Universitetssjukhuset Östra
Gothenburg, Sweden, 41685