Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients



Status:Withdrawn
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:3/31/2019
Start Date:December 7, 2016
End Date:February 25, 2019

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Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients

The purpose of the study is to investigate the safety and efficacy of oral vancomycin in
patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The
primary endpoint is looking at the effect of the drug on liver function tests, an important
surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a
decrease in liver function tests at 1 year, changes in bilirubin and adverse events.
Effective treatment at the onset of PSC recurrence may lead to decreases in disease
progression, recurrent liver failure, and repeat liver transplantation.


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
We found this trial at
1
site
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Shamita Shah, MD
Phone: 504-842-4015
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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mi
from
New Orleans, LA
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