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New treatment option for Primary Sclerosing Cholangitis
Official title Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
ClinicalTrials.gov ID: NCT05912387
What this study is testing
What is Rosuvastatin?
Rosuvastatin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Hypercholesterolemia with BMI \< 25.0 for the comparison arm
You likely can't join if
- 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...
- 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
See the full eligibility 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)...
- Hypercholesterolemia with BMI \< 25.0 for the comparison arm
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.