Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

  • STATUS
    Recruiting
  • End date
    May 15, 2027
  • participants needed
    700
  • sponsor
    Annika Bergquist
Updated on 15 September 2021

Summary

This is a randomized, double-blind, placebo controlled multicenter study.

A total of 700 patients will be included.

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.

Details
Condition Primary Sclerosing Cholangitis
Treatment simvastatin 40mg, Placebo Oral Tablet
Clinical Study IdentifierNCT04133792
SponsorAnnika Bergquist
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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