Effect of Simvastatin on Primary Sclerosing Cholangitis

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

This study is testing if taking simvastatin for five years can help people with primary sclerosing cholangitis live longer and avoid serious complications.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Karolinska University Hospital (Academic / other)
• Locations: 15 sites (Malmö, Skåne and 14 other locations)
• Trial ID: NCT04133792 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of long-term simvastatin use on the prognosis of patients with primary sclerosing cholangitis (PSC). It is a randomized, double-blind, placebo-controlled study involving 700 participants who will receive either 40 mg of simvastatin or a placebo daily for five years. The primary outcomes include rates of death, liver transplantation, cholangiocarcinoma, and bleeding from esophageal varices. The study aims to determine if simvastatin can improve the overall prognosis for individuals suffering from PSC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of primary sclerosing cholangitis.

Not a fit: Patients who have undergone liver transplantation or have secondary sclerosing cholangitis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option to improve the prognosis of patients with primary sclerosing cholangitis.

How similar studies have performed: While the use of statins in liver diseases has been explored, this specific approach in PSC is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Malmö, Skåne and 14 other locations

• Skåne Universitetssjukhus — Malmö, Skåne, Sweden (Recruiting)
• Norrlands Universitetssjukhus — Umeå, Västerbotten, Sweden (Recruiting)
• Sahlgrenska Universitetssjukhuset — Göteborg, Västra Götaland, Sweden (Recruiting)
• Södra Älvsborgs sjukhus — Borås, Sweden (Not_yet_recruiting)
• Sahlgrenska Universitetssjukhuset Östra — Göteborg, Sweden (Recruiting)
• Karlstads centralsjukhus — Karlstad, Sweden (Recruiting)
• Capio S:t Görans sjukhus — Stockholm, Sweden (Recruiting)
• Ersta sjukhus — Stockholm, Sweden (Not_yet_recruiting)
• Karolinska University Hospital — Stockholm, Sweden (Recruiting)
• Karolinska University Hospital Solna — Stockholm, Sweden (Recruiting)
• Danderyds sjukhus — Stockholm, Sweden (Recruiting)
• Norra Älvsborgs länssjukhus — Trollhättan, Sweden (Not_yet_recruiting)
• Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
• Örebro Universitetssjukhus — Örebro, Sweden (Recruiting)
• Universitetssjukhuset i Linköping — Linköping, Östergötland, Sweden (Recruiting)

Study contacts

• Principal investigator: Annika Bergquist, MD PhD — Karolinska University Hospital
• Study coordinator: Annika Bergquist, MD PhD

Conditions Primary Sclerosing Cholangitis