Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) (NCT04133792) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Sweden571 participantsStarted 2020-10-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival
Timeframe: Time from the date of randomization to the date of death, assessed up to 5 years.
2
Listing for liver transplantation
Timeframe: Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years.
3
Time to first varices bleeding
Timeframe: Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years.
4
Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer.
Timeframe: Time from the date of randomization to cancer diagnosis, assessed up to 5 years.