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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04133792
Other study ID # 2018-000814-39
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 1, 2020
Est. completion date May 15, 2027

Study information

Verified date October 2022
Source Karolinska University Hospital
Contact Annika Bergquist, MD PhD
Phone 0707214907
Email annika.bergquist@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo controlled multicenter study. A total of 700 patients will be included. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date May 15, 2027
Est. primary completion date May 15, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Drug:
Simvastatin 40mg
40 mg orally daily for 5 years.
Placebo oral tablet
40 mg orally daily for 5 years.

Locations

Country Name City State
Sweden Södra Älvsborgs sjukhus Borås
Sweden Sahlgrenska Universitetssjukhuset Göteborg Västra Götaland
Sweden Sahlgrenska Universitetssjukhuset Östra Göteborg
Sweden Karlstads centralsjukhus Karlstad
Sweden Universitetssjukhuset i Linköping Linköping Östergötland
Sweden Skåne Universitetssjukhus Malmö Skåne
Sweden Örebro Universitetssjukhus Örebro
Sweden Capio S:t Görans sjukhus Stockholm
Sweden Danderyds sjukhus Stockholm
Sweden Ersta sjukhus Stockholm
Sweden Karolinska University Hospital Stockholm
Sweden Karolinska University Hospital Solna Stockholm
Sweden Norra Älvsborgs länssjukhus Trollhättan
Sweden Norrlands Universitetssjukhus Umeå Västerbotten
Sweden Akademiska sjukhuset Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Annika Bergquist

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival 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.
Primary Listing for liver transplantation 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.
Primary Time to first varices bleeding 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.
Primary Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer. 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 Effect on serum concentration of alkaline phosphatase (ALP). Assessment of changes in the serum concentration of alkaline phosphatase. Assessed yearly up to 5 years.
Secondary Effect on serum concentration of bilirubin Assessment of changes in the serum concentration of bilirubin. Assessed yearly up to 5 years.
Secondary Effect on the progress of PSC by liver failure measurement 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.
Secondary Effect on the progress of PSC by liver failure measurement. Assessment of liver failure using Child Pugh Score Assessed at every visit except the 3 months visit, up to 5 years.
Secondary Effect on the progress of PSC assessed by cholangiography at MRI. Progress assessed by cholangiography MRI Assessed at inclusion and the 60 months visit.
Secondary Effect on the progress of PSC assessed by elastography Assessment of fibrosis stage using elastography. Assessed yearly up to 5 years.
Secondary Effect on the progress of PSC assessed by clinical symptoms Assessment of symptoms including itching and bacterial cholangitis that requires treatment, ascites and encephalopathy. Assessed yearly up to 5 years.
Secondary Effect on the progress of PSC assessed by measurement of biliary dysplasia Biliary dysplasia from brush samples taken at endoscopic retrograde cholangiopancreatography (ERCP). Assessed upon clinical indication, up to 5 years.
Secondary Effect on the development of colon cancer or colon dysplasia. Development of colon cancer and/or colon dysplasia according to hospital patient records. Assessed at 60 months.
Secondary Effect on the progress of PSC assessed by serum fibrosis markers Fib-4, ELF (if funded) Assessed yearly up to 5 years
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