Actively Recruiting
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
Led by Stanford University · Updated on 2026-02-27
15
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, greater than or equal to 18 years of age
- Established diagnosis of PSC by cholangiographic findings or liver biopsy plus inflammatory bowel disease diagnosis per guidelines for the PSC-IBD arm
- Hypercholesterolemia with body mass index less than 25.0 for the comparison arm
You will not qualify if you...
- Diagnosis of PSC-autoimmune hepatitis overlap syndrome
- Women who are pregnant, nursing, or expect to be pregnant
- Any comorbidity causing secondary sclerosing cholangitis such as IgG4-associated cholangitis, recurrent bacterial or pyogenic cholangitis, ischemic cholangiopathy, surgical biliary trauma, cholangiocarcinoma, or portal hypertensive biliopathy
- Serious medical conditions unless approved by a physician
- Prior statin therapy use before study start
- Known allergy to statin therapy
- Aspartate aminotransferase or alanine aminotransferase levels greater than 5 times the upper limit of normal
- Bilirubin greater than 3.0 mg/dL
- Recent antibiotic use within 90 days
- Concurrent use of immunosuppressive medications over specified doses
- Active use of fibrate or ritonavir-containing drugs
- Familial hypercholesterolemia or inherited lipid disorders
- Recent heart attack or stroke
- Body mass index greater than 25.0 for the comparison arm
- Chronic kidney disease stage 5 or end-stage renal disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
T
Touran Fardeen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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