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

Annika Bergquist

Status and phase: Enrolling; Phase 3

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Placebo oral tablet; Drug: Simvastatin 40mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04133792

2018-000814-39

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

700 participants in 2 patient groups, including a placebo group

Simvastatin

Experimental group

Description:

Simvastatin 40 mg administered orally daily for 5 years.

Treatment:

Drug: Simvastatin 40mg

Placebo

Placebo Comparator group

Description:

Placebo for Simvastatin 40 mg administered orally daily for 5 years.

Treatment:

Drug: Placebo oral tablet