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

NCT04133792 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

Simvastatin 40mg

40 mg orally daily for 5 years.

DRUG

Placebo oral tablet

40 mg orally daily for 5 years.

Sponsors & Collaborators

  • Annika Bergquist

    lead OTHER

Principal Investigators

  • Annika Bergquist, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2028-03-31
Completion
2030-03-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133792 on ClinicalTrials.gov