Vancomycin for Primary Sclerosing Cholangitis (NCT03710122) | Clinical Trial Compass
TerminatedPhase 2/3
Vancomycin for Primary Sclerosing Cholangitis
Stopped: Funding terminated
United States102 participantsStarted 2020-01-23
Plain-language summary
To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis.
Funding Source - FDA OOPD
Who can participate
Age range18 Years – 76 Years
SexALL
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Inclusion criteria
✓. Male or female subject age 18-76 years
✓. Diagnosis of PSC consistent with the guidelines published by the American Association for the Study of Liver Diseases (AASLD).39 All subjects must have an elevated serum ALP of at least 1.5 times upper limit of normal at baseline plus cholangiographic evidence of PSC, as demonstrated by magnetic resonance imaging, endoscopic retrograde cholangiography, direct cholangiography, or liver biopsy.
✓. Total bilirubin at screening must be ≤ 2 times upper limit of normal
✓. An ultrasound (or equivalent imaging modality) that excludes biliary obstruction and malignancy within 6 months of study entry,
✓. If a patient is on any of the following medications and/or supplements, he or she is expected to remain on the same daily dose through the treatment period: UDCA, azathioprine, prednisone (or an equivalent steroid compound), methotrexate, a 5-aminosalicylic acid, biologic therapy, and/or a probiotic.
✓. If a patient has been on obeticholic acid or other experimental therapies for PSC, they must complete a 3 month washout period before study entry
✓. PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
✓. Must agree to comply with the study protocol and provide informed consent.
Exclusion criteria
✕. Administration of an antibiotic within 3 months prior to the study,
✕. Pregnancy or attempting to become pregnant or breastfeeding,