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RecruitingAccepts healthy volunteersEarly Phase 1

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

Stanford University · NCT05912387

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
15
US sites recruiting
1
Study start
May 31, 2023
Record last updated
February 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Rosuvastatin

Conditions: Primary Sclerosing Cholangitis; Inflammatory Bowel Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Stanford University

    Stanford, CA 94305

    Site contact: Touran Fardeen · tfardeen@stanford.edu

Study contacts (from the official record)

  • Touran Fardeen · (650) 725-5890 · tfardeen@stanford.edu
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Statin Therapy in Primary Sclerosing Cholangitis (PSC): a… (NCT05912387) | Bored Studies