Vancomycin for Primary Sclerosing Cholangitis

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis. Funding Source - FDA OOPD

Key facts

Study ID: NCT03710122
Run by: Elizabeth Carey
People needed: 102
Starts: 2020-01-23
Expected to finish: 2025-03-20
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Administration of an antibiotic within 3 months prior to the study,
Pregnancy or attempting to become pregnant or breastfeeding,
Presence of any of the following:
i. Hepatitis B infection
ii. Hepatitis C infection (antibody positive); patients with a history of hepatitis C infection will be eligible for this study if they have undetectable levels of HCV RNA
iii. Other cholestatic liver diseases such as primary biliary cholangitis and cholestatic diseases of pregnancy
iv. Metabolic liver diseases such as Wilson's disease and hemochromatosis
v. Inherited diseases of the liver such as α-1 antitrypsin deficiency
vi. Immunoglobulin G4-related cholangitis
vii. PSC with concomitant autoimmune hepatitis (AIH) and/or primary biliary cholangitis (previously known as primary biliary cirrhosis)
viii. Secondary sclerosing cholangitis (SSC),
ix. Active acute ascending cholangitis requiring antibiotics
x. CCA (malignant biliary stricture, neoplasm, and cytology/histopathology or positive fluorescence in situ hybridization (FISH) consistent with adenocarcinoma of the bile duct)
xi. A liver biopsy, if one has been previously obtained, which showed non-alcoholic steatohepatitis (NASH). Patients with suspected fatty liver by imaging will not be excluded
xii. Presence of decompensated cirrhosis such as hepatic encephalopathy, hepato-renal syndrome and hepato-pulmonary syndrome,
xiii. History of liver transplantation, anticipated need for liver transplantation within 12 months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15
xiv. Ongoing alcohol abuse (>4 drinks per day for men, and >2 drinks per day for women)
xv. History of allergic reaction to vancomycin,
xvi. Moderate-to-severe renal impairment with a calculated creatinine clearance of < 60mL/min
xvii. HIV/AIDS,
xviii. Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study.

Where it is running

Mayo Clinic Arizona — Phoenix, Arizona, United States
Arizona State University — Tempe, Arizona, United States
Mayo Clinic Florida — Jacksonville, Florida, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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