PSCIBD (general)Recruiting
Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
Early Phase 1 · Testing Rosuvastatin · 1 site · Stanford University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Rosuvastatin (a drug) to better understand how the disease works. Condition(s) listed: Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 80
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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…
- Hypercholesterolemia with BMI < 25.0 for the comparison arm
There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- The study has 1 group.
- Start date: 2023-05-31.
- Main results expected around 2027-05-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Groups in this study
- Rosuvastatin therapy (listed as: experimental group)
Main thing being measured
- Change in bile acid (BA) profile: total bile acid (Baseline and week 12)
- Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio (Baseline and week 12)
- Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio (Baseline and week 12)
In the researchers’ words
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.
Words you might see
- ULN: upper limit of normal: the top of the usual range for a lab test.
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- Cholangiocarcinoma: cancer of the bile ducts.
- Biopsy / histology: a small tissue sample examined under a microscope.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis; Inflammatory Bowel Diseases |
| Lead sponsor | Stanford University |
| Enrollment | 15 (estimated) |
| Start date | 2023-05-31 |
| Primary completion (est.) | 2027-05-31 |
| First posted | 2023-06-22 |
| Last updated | 2026-02-27 |
| Official title | The Effect of Statin Therapy on Bile Acid Physiology and the Microbiome in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study |
| ClinicalTrials.gov ID | NCT05912387 |
Interventions
- Rosuvastatin (Drug)
Rosuvastatin 20 mg tablet once daily by mouth
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University | Stanford, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.