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Active, Not Recruiting

NCT Number: NCT04133792

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Sclerosing Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholangitis Cholangitis, Sclerosing Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Skåne Universitetssjukhus, Malmö, Skåne County, Sweden

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About this study

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. Marschall, E. Nilsson, N. Nyhlin, M. Werner, A. Klein, et al.

British Journal of Gastroenterolgy 2022 Vol. 1 Pages 235-241.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simvastatin 40mg

Drug

40 mg orally daily for 5 years.

Placebo oral tablet

Drug

40 mg orally daily for 5 years.

Primary outcomes

  1. Overall survival

    Time frame: Time from the date of randomization to the date of death, assessed up to 5 years.

    Overall survival from time to randomization to death from any cause.

  2. Listing for liver transplantation

    Time frame: Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years.

    Date the subject is getting registered on the waiting list for liver transplantation.

  3. Time to first varices bleeding

    Time frame: Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years.

    Date of the subject's first varices bleeding according to hospital patient records.

  4. Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer.

    Time frame: Time from the date of randomization to cancer diagnosis, assessed up to 5 years.

    Diagnosis of cancer of bile duct cancer or gall bladder, or hepatocellular cancer according to hospital patient records.

Secondary outcomes

  1. Effect on serum concentration of alkaline phosphatase (ALP).

    Time frame: Assessed yearly up to 5 years.

    Assessment of changes in the serum concentration of alkaline phosphatase.

  2. Effect on serum concentration of bilirubin

    Time frame: Assessed yearly up to 5 years.

    Assessment of changes in the serum concentration of bilirubin.

  3. Effect on the progress of PSC by liver failure measurement

    Time frame: Assessed at every visit except the 3 months visit, up to 5 years.

    Assessment of liver failure using Model for End Stage Liver Disease (MELD) Score (biochemical and clinical variables).

  4. Effect on the progress of PSC by liver failure measurement.

    Time frame: Assessed at every visit except the 3 months visit, up to 5 years.

    Assessment of liver failure using Child Pugh Score

  5. Effect on the progress of PSC assessed by cholangiography at MRI.

    Time frame: Assessed at inclusion and the 60 months visit.

    Progress assessed by cholangiography MRI

  6. Effect on the progress of PSC assessed by elastography

    Time frame: Assessed yearly up to 5 years.

    Assessment of fibrosis stage using elastography.

  7. Effect on the progress of PSC assessed by clinical symptoms

    Time frame: Assessed yearly up to 5 years.

    Assessment of symptoms including itching and bacterial cholangitis that requires treatment, ascites and encephalopathy.

  8. Effect on the progress of PSC assessed by measurement of biliary dysplasia

    Time frame: Assessed upon clinical indication, up to 5 years.

    Biliary dysplasia from brush samples taken at endoscopic retrograde cholangiopancreatography (ERCP).

  9. Effect on the development of colon cancer or colon dysplasia.

    Time frame: Assessed at 60 months.

    Development of colon cancer and/or colon dysplasia according to hospital patient records.

  10. Effect on the progress of PSC assessed by serum fibrosis markers

    Time frame: Assessed yearly up to 5 years

    Fib-4, ELF (if funded)

Sponsors and collaborators

Lead sponsor

Annika Bergquist

Other

Registry information

Official study title

Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study

Acronym: PiSCATIN

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Oct 21, 2019
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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