Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03046901
• Date of registration: 31/01/2017
• Prospective Registration: No
• Primary sponsor: Ochsner Health System
• Public title: Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients
• Scientific title: Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients
• Date of first enrolment: December 7, 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03046901
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. History of prior orthotopic liver transplant or liver and kidney transplant.

2. Recurrent PSC confirmed by clinical labs (AST/ALT greater than 19 or ALKP greater than
normal), imaging (MRCP or ERCP), and/or liver biopsy consistent with recurrent PSC.

3. No clinical evidence of liver transplant rejection and stability of post-transplant
immune suppression dosing for three months prior to enrollment in the study

4. No changes to therapy for inflammatory bowel disease for at least three months prior
to enrollment (for patients with history of IBD)

5. Patients on ursodiol must have been on a stable dose for two weeks prior to enrollment
and dose must be stable for the remainder of the clinical trial.

6. All patients with inflammatory bowel disease must have had a colonoscopy within a year
prior to enrollment

7. No antibiotics for 2 months before starting vancomycin

8. No probiotics for 1 month prior to starting vancomycin or during study period

Exclusion Criteria

1. Allergy to vancomycin

2. Pre-existing advanced malignancies

3. Pregnancy or Lactation

4. Inability to provide consent

5. Findings suggestive of liver disease of other etiology such as chronic alcoholic liver
disease, chronic hepatitis B or C infection, autoimmune hepatitis, primary biliary
cirrhosis, hemochromatosis, Wilson's disease, or congenital biliary disease.

6. Current biliary obstruction

7. Active infection

8. Involvement in any other investigational study



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Post- Orthotopic Liver Transplantation

Intervention(s)

Drug: Vancomycin

Primary Outcome(s)

Liver Function Test [Time Frame: 12 weeks]

Secondary Outcome(s)

Liver Function Test [Time Frame: 1 year]

Secondary ID(s)

Pro00013111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors