Early Phase 1 Primary Biliary Cholangitis Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 or older of any gender
- People with a confirmed diagnosis of PSC (a liver and bile duct condition), identified through specific imaging or a liver biopsy, who also have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) — for the main study group
- People with high cholesterol and a Body Mass Index (BMI) under 25 (considered a "normal" weight range) — for the comparison group
Who may not be able to join:
- People who have both PSC and a condition called autoimmune hepatitis at the same time
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study
- People whose bile duct problems are caused by other known conditions, such as IgG4-related disease, repeated bile duct infections, bile duct injury from surgery, bile duct cancer, or certain other specific conditions (confirm with trial site)
- People with a serious medical illness, unless a doctor has given written approval for them to participate
- People who are currently taking or have previously taken statin medications (cholesterol-lowering drugs) before the study begins
- People with a known allergy to statin medications
- People with significantly elevated liver enzyme levels (AST or ALT more than 5 times the normal upper limit) (confirm with trial site)
- People with a bilirubin level above 3.0 mg/dL, which can indicate liver problems (confirm with trial site)
- People who have taken antibiotics within the last 90 days
- People currently taking immune-suppressing medications, such as steroids above a certain dose or other specific drugs
- People currently using a type of cholesterol medication called a fibrate
- People currently taking any medication containing ritonavir (commonly used in HIV treatment)
- People with inherited cholesterol or lipid disorders, such as familial hypercholesterolemia
- People who have recently had a heart attack or stroke
- People with a BMI over 25 — for the comparison group only
- People with very advanced kidney disease (stage 5 chronic kidney disease or kidney failure)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sidhartha Sinha, MD, Stanford University
Phone: (650) 725-5890
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in bile acid (BA) profile: total bile acid; Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio; Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio; Change in pathogen density in the small intestine; Change in bacterial gene expression profile in the small intestine
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.