NCT05912387 Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
| NCT ID | NCT05912387 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Stanford University |
| Condition | Primary Sclerosing Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-05-31 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2023-05-31 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Sidhartha Sinha, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05912387 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Primary Sclerosing Cholangitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05912387 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05912387 currently recruiting?
Yes, NCT05912387 is actively recruiting participants. Contact the research team at tfardeen@stanford.edu for enrollment information.
Where is the NCT05912387 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT05912387 clinical trial?
NCT05912387 is sponsored by Stanford University. The principal investigator is Sidhartha Sinha, MD at Stanford University. The trial plans to enroll 15 participants.