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

August 29, 2025 updated by: Annika Bergquist

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

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

Study Type

Interventional

Enrollment (Actual)

571

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 41685
        • Sahlgrenska universitetssjukhuset Östra
      • Karlstad, Sweden, 652 30
        • Karlstads centralsjukhus
      • Lidköping, Sweden
        • Skaraborgs Sjukhus
      • Stockholm, Sweden, 182 57
        • Danderyds Sjukhus
      • Stockholm, Sweden, 141 57
        • Karolinska University Hospital
      • Stockholm, Sweden, 171 64
        • Karolinska University Hospital Solna
      • Uppsala, Sweden, 751 85
        • Akademiska sjukhuset
      • Örebro, Sweden, 701 85
        • Orebro universitetssjukhus
    • Skåne County
      • Malmo, Skåne County, Sweden, 222 42
        • Skåne Universitetssjukhus
    • Västerbotten County
      • Umeå, Västerbotten County, Sweden, 907 37
        • Norrlands universitetssjukhus
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
    • Östergötland County
      • Linköping, Östergötland County, Sweden, 581 85
        • Universitetssjukhuset i Linköping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simvastatin
Simvastatin 40 mg administered orally daily for 5 years.
Drug: Simvastatin 40mg
40 mg orally daily for 5 years.
Placebo Comparator: Placebo
Placebo for Simvastatin 40 mg administered orally daily for 5 years.
Drug: Placebo oral tablet
40 mg orally daily for 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time from the date of randomization to the date of death, assessed up to 5 years.
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.
Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years.
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.
Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years.
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.
Time from the date of randomization to cancer diagnosis, assessed up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed yearly up to 5 years.
Effect on serum concentration of bilirubin
Time Frame: Assessed yearly up to 5 years.
Assessment of changes in the serum concentration of bilirubin.
Assessed yearly up to 5 years.
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).
Assessed at every visit except the 3 months visit, up to 5 years.
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
Assessed at every visit except the 3 months visit, up to 5 years.
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
Assessed at inclusion and the 60 months visit.
Effect on the progress of PSC assessed by elastography
Time Frame: Assessed yearly up to 5 years.
Assessment of fibrosis stage using elastography.
Assessed yearly up to 5 years.
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.
Assessed yearly up to 5 years.
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).
Assessed upon clinical indication, up to 5 years.
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.
Assessed at 60 months.
Effect on the progress of PSC assessed by serum fibrosis markers
Time Frame: Assessed yearly up to 5 years
Fib-4, ELF (if funded)
Assessed yearly up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Annika Bergquist

Investigators

  • Principal Investigator: Annika Bergquist, MD PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

October 17, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-000814-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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