Vancomycin for Primary Sclerosing Cholangitis

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To find out if vancomycin is a safe and effective therapy for primary sclerosing cholangitis.

Funding Source - FDA OOPD

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arizona State University; Elizabeth Carey
• Collaborators: Arizona State University; Mayo Clinic; University of Calgary
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

1. Male or female subject age 18-75 years

2. Diagnosis of PSC consistent with the guidelines published by the American Association for the Study of Liver Diseases (AASLD). 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.

3. An ultrasound (or equivalent imaging modality) that excludes biliary obstruction and malignancy within 6 months of study entry.

4. 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.

5. PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's disease.

6. Must agree to comply with the study protocol and provide informed consent.

Exclusion Criteria:

1. Administration of an antibiotic within 3 months prior to the study 2. Pregnancy or attempting to become pregnant or breastfeeding 3. Presence of any of the following:

1. Hepatitis B infection

2. 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

3. Other cholestatic liver diseases such as primary biliary cholangitis and cholestatic diseases of pregnancy

4. Metabolic liver diseases such as Wilson's disease and hemochromatosis

5. Inherited diseases of the liver such as α-1 antitrypsin deficiency

6. Immunoglobulin G4-related cholangitis

7. PSC with concomitant autoimmune hepatitis (AIH) &/or primary biliary cholangitis (previously known as primary biliary cirrhosis)

8. Secondary sclerosing cholangitis (SSC)

9. Active acute ascending cholangitis requiring antibiotics

10. CCA (malignant biliary stricture, neoplasm, & cytology/histopathology or positive fluorescence in situ hybridization (FISH) consistent with adenocarcinoma of the bile duct)

11. A liver biopsy, if one has been previously obtained, which showed non-alcoholic steatohepatitis (NASH). Patients with suspected fatty liver imaging will not be excluded

12. Presence of complications of advanced PSC such as hepatic encephalopathy, portal hypertension, hepato-renal syndrome and hepato-pulmonary syndrome

13. 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

14. Ongoing alcohol abuse (>4 drinks per day for men, and >2 drinks per day for women)

15. History of allergic reaction to vancomycin

16. Moderate-to-severe renal impairment with a calculated creatinine clearance of <60mL/min

r. HIV/AIDS q. Any other conditions or abnormalities that, in that opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study