Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
This study examines whether statin medications (commonly used for cholesterol) might help treat primary sclerosing cholangitis (PSC), a serious liver disease with no current cure. Researchers will use advanced testing methods to understand how statins affect the disease and why some patients develop PSC in the first place.
Key Objective: The trial tests whether statins can slow or improve PSC progression and reduce the risk of cancer and infection in PSC patients.
Who to Consider: Patients with diagnosed primary sclerosing cholangitis who are interested in exploring potential new treatment options should consider enrolling.
Trial Parameters
Brief Summary
PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection. Additionally, many patients require a liver transplant. Progress towards a cure has been severely limited by an incomplete understanding of why patients develop PSC. The investigators aim to close this gap by conducting a pilot human study in patients with PSC, using statin therapy as a model
Eligibility Criteria
Inclusion Criteria: * Males and females, greater than or equal to 18 years of age * Established diagnosis of PSC, defined by either appropriate cholangiographic findings or supportive liver biopsy plus an established diagnosis of inflammatory bowel disease (IBD - Crohn's disease or ulcerative colitis) per American College of Gastroenterology (ACG) guidelines for the PSC-IBD arm * Hypercholesterolemia with BMI \< 25.0 for the comparison arm Exclusion Criteria: * Diagnosis of PSC-autoimmune hepatitis overlap syndrome * Woman who are pregnant, nursing, or expect to be pregnant * The presence of any comorbidity known to cause secondary sclerosing cholangitis, including: immunoglobulin G-4 (IgG4), associated cholangitis, recurrent bacterial cholangitis, recurrent pyogenic cholangitis, ischemic cholangiopathy, surgical biliary trauma, cholangiocarcinoma, and portal hypertensive biliopathy * Diagnosis of a serious medical condition (unless approved in writing by a physician) * Patients taking