Clinical trial NCT03046901: Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients
Official title: Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Sclerosing Cholangitis
Post- Orthotopic Liver Transplantation
Keywords: Vancomycin
Primary Sclerosing cholangitis
Post-liver transplantation
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be conducted as a prospective open-label pilot study of up to 20 patients who will receive oral vancomycin for 3-12 months as treatment for recurrent PSC after liver transplantation. There will be no masking or randomization.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Liver Function Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Liver Function Test
timeFrame: 1 year
measure: Liver Function Test
timeFrame: 1 year
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
References: