Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Not Applicable

Withdrawn

• Conditions: Primary Sclerosing Cholangitis; Post- Orthotopic Liver Transplantation
• Interventions: Drug: Vancomycin

• Registration Number: NCT03046901
• Lead Sponsor: Ochsner Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-07
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-08
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vancomycin group	Vancomycin	It is a single arm open label study and will constitute only one group that will be taking vancomycin for recurrent PSC post liver transplantation.

Primary Outcome Measures

Name	Time	Method
Liver Function Test	12 weeks	Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Secondary Outcome Measures

Name	Time	Method
Liver Function Test	1 year	Bilirubin

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States