Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
NCT ID: NCT04133792
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
571 participants
INTERVENTIONAL
2020-10-01
2030-03-31
Brief Summary
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A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough
The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices.
Subjects will be randomized (1:1) between Simvastatin and placebo.
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Detailed Description
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Long Term Effect of Simvastatin in Primary Sclerosing Cholangitits: A Placebo-Controlled, Double-Blind, Multicenter Phase III Study (Piscatin)
A. Bergquist, H. U. Marschall, E. Nilsson, N. Nyhlin, M. Werner, A. Klein, et al.
British Journal of Gastroenterolgy 2022 Vol. 1 Pages 235-241.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Simvastatin
Simvastatin 40 mg administered orally daily for 5 years.
Simvastatin 40mg
40 mg orally daily for 5 years.
Placebo
Placebo for Simvastatin 40 mg administered orally daily for 5 years.
Placebo oral tablet
40 mg orally daily for 5 years.
Interventions
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Simvastatin 40mg
40 mg orally daily for 5 years.
Placebo oral tablet
40 mg orally daily for 5 years.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Annika Bergquist
OTHER
Responsible Party
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Annika Bergquist
Professor
Principal Investigators
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Annika Bergquist, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Skåne Universitetssjukhus
Malmo, Skåne County, Sweden
Norrlands Universitetssjukhus
Umeå, Västerbotten County, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götaland County, Sweden
Sahlgrenska Universitetssjukhuset Östra
Gothenburg, , Sweden
Karlstads centralsjukhus
Karlstad, , Sweden
Skaraborgs sjukhus
Lidköping, , Sweden
Örebro Universitetssjukhus
Örebro, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Karolinska University Hospital Solna
Stockholm, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Universitetssjukhuset i Linköping
Linköping, Östergötland County, Sweden
Countries
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References
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Lindqvist C, Ingre M, Kechagias S, Nilsson E, Molinaro A, Rorsman F, Bergquist A. Dietary Habits of Individuals With Primary Sclerosing Cholangitis-Poor Fat-Soluble Vitamin Intake and Dietary Quality. Liver Int. 2025 Apr;45(4):e16182. doi: 10.1111/liv.16182. Epub 2024 Nov 27.
Other Identifiers
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2018-000814-39
Identifier Type: -
Identifier Source: org_study_id
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