NCT04133792

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: Annika Bergquist · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Simvastatin 40mg	40 mg orally daily for 5 years.
DRUG	Placebo oral tablet	40 mg orally daily for 5 years.

Timeline

• Start date: 2020-10-01
• Primary completion: 2028-03-31
• Completion: 2030-03-31
• First posted: 2019-10-21
• Last updated: 2025-09-05

Locations

12 sites across 1 country: Sweden