Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

Launched by STANFORD UNIVERSITY · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of statin therapy on patients with Primary Sclerosing Cholangitis (PSC), a serious liver disease that currently has no cure. PSC can lead to increased risks of cancer and infections, and many patients end up needing a liver transplant. The study aims to better understand how statins, which are commonly used to lower cholesterol, might help in managing this condition. Researchers are particularly interested in gathering insights from patients who also have inflammatory bowel diseases like Crohn's disease or ulcerative colitis.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of PSC, along with certain types of inflammatory bowel disease. Additionally, those in a specific comparison group should have high cholesterol but a healthy body mass index (BMI). Participants can expect to undergo various assessments and treatments related to statin therapy. It’s important to note that individuals with certain health conditions or who are currently taking specific medications may not be able to join the study. If you're considering participation, this could be a valuable opportunity to contribute to research that may improve understanding and treatment options for PSC.

Gender

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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 statin therapy prior to study initiation
• • Patients with known clinically allergy to statin therapy
• • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
• • Bilirubin greater than 3.0 mg/dL
• • Recent use of antibiotics (within the last 90 days)
• • Concurrent use of any immunosuppressive medications (such as any calcineurin inhibitor, steroids at a dose greater than 10 mg of prednisone-equivalents per day)
• • Actively using a fibrate drug
• • Actively using a ritonavir containing drug
• • Familial hypercholesterolemia or other inherited disorder of lipid metabolism
• • Recent myocardial infarction or cerebrovascular accident
• • Body mass index \> 25.0 for the comparison arm
• • Chronic kidney disease stage 5 or end-stage renal disease