Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
Study NCT ID:
NCT04133792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2019-10-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)
Sponsor:
Annika Bergquist
Organization:
Study Overview
Official Title:
Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PiSCATIN
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: