Recruiting
Early Phase 1

Statin Therapy

Sponsor:

Stanford University

Code:

NCT05912387

Conditions

Primary Sclerosing Cholangitis

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Rosuvastatin

Study Details

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

Conditions

Primary Sclerosing Cholangitis

Inflammatory Bowel Diseases

Study ID

NCT05912387

Start date

May 31, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Rosuvastatin therapy

Participants will receive rosuvastatin for 12 weeks followed by a 2 week washout period prior to the final follow-up visit. All patients will receive the study drug, and will serve as their own control. No participants will receive placebo. Rosuvastatin is FDA approved for treatment of high cholesterol, but its use in this trial is off label.

Interventions

Rosuvastatin

Rosuvastatin 20 mg tablet once daily by mouth

Primary outcome measure

  • Change in bile acid (BA) profile: total bile acid [ Time Frame: Baseline and week 12 ]
  • Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio [ Time Frame: Baseline and week 12 ]
  • Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio [ Time Frame: Baseline and week 12 ]
  • Change in pathogen density in the small intestine [ Time Frame: Baseline and week 12 ]
  • Change in bacterial gene expression profile in the small intestine [ Time Frame: Baseline and week 12 ]

Central Contacts and Locations

Central contacts

Touran Fardeen

(650) 725-5890tfardeen@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Touran Fardeen

tfardeen@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Statin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.