Using statins to understand and treat Primary Sclerosing Cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of rosuvastatin, a commonly used cholesterol-lowering medication, on patients with Primary Sclerosing Cholangitis (PSC). The research aims to explore how statin therapy influences bile acid profiles and the microbiome, potentially revealing insights into the biological mechanisms underlying PSC. The study will consist of three phases: baseline measurements, treatment with rosuvastatin, and follow-up assessments after treatment. All participants will receive the active medication, as there is no placebo group in this pilot study.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Sidhartha Sinha, MD — Stanford University
• Study coordinator: Touran Fardeen
• Email: tfardeen@stanford.edu
• Phone: (650) 725-5890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.