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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05912387
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Inflammatory Bowel Diseases
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Rosuvastatin — DRUG
    Rosuvastatin 20 mg tablet once daily by mouth

Study Details

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

Key Dates

Start date
May 31, 2023
Status verified
Feb 2026
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Change in bile acid (BA) profile: total bile acid [ Time Frame: Baseline and week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Touran Fardeen
[email protected]

Find similar trials in Stanford, CA

By research site
Stanford University· Stanford, CA

Related Studies