Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT04133792
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04133792
Study Brief:
Protocol Section:
NCT04133792