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Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Primary Purpose

Primary Sclerosing Cholangitis, Post- Orthotopic Liver Transplantation

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vancomycin

About this trial

This is an interventional prevention trial for Primary Sclerosing Cholangitis focused on measuring Vancomycin, Primary Sclerosing cholangitis, Post-liver transplantation

Eligibility Criteria

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Inclusion Criteria:

History of prior orthotopic liver transplant or liver and kidney transplant.
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.
No clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study
No changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of IBD)
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.
All patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment
No antibiotics for 2 months before starting vancomycin
No probiotics for 1 month prior to starting vancomycin or during study period

Exclusion Criteria

Allergy to vancomycin
Pre-existing advanced malignancies
Pregnancy or Lactation
Inability to provide consent
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.
Current biliary obstruction
Active infection
Involvement in any other investigational study

Sites / Locations

Ochsner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vancomycin group

Arm Description

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.

Outcomes

Primary Outcome Measures

Liver Function Test

Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Secondary Outcome Measures

Liver Function Test

Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Liver Function Test

Bilirubin

Full Information

NCT ID

NCT03046901

First Posted

January 31, 2017

Last Updated

March 27, 2019

Sponsor

Ochsner Health System

1. Study Identification

Unique Protocol Identification Number

NCT03046901

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Withdrawn

Why Stopped

0 subjects enrolled

Study Start Date

December 7, 2016 (Actual)

Primary Completion Date

February 25, 2019 (Actual)

Study Completion Date

February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ochsner Health System

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis, Post- Orthotopic Liver Transplantation

Keywords

Vancomycin, Primary Sclerosing cholangitis, Post-liver transplantation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vancomycin group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Other Intervention Name(s)

Vancocin

Intervention Description

Vancomycin belongs to the family of medicines called antibiotics.When taken by mouth, is used to treat Clostridium difficile-associated diarrhea (also called C diff). C diff is a type of bacteria that causes severe diarrhea. Oral Vancomycin is also used to treat enterocolitis caused by a certain bacteria (e.g., Staphylococcus aureus). Subjects enrolled in the study will take 500 mg capsule, 3 times per day for 3-12 weeks.

Primary Outcome Measure Information:

Title

Liver Function Test

Description

Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Liver Function Test

Description

Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Time Frame

1 year

Title

Liver Function Test

Description

Bilirubin

Time Frame

1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: History of prior orthotopic liver transplant or liver and kidney transplant. 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. No clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study No changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of IBD) 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. All patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment No antibiotics for 2 months before starting vancomycin No probiotics for 1 month prior to starting vancomycin or during study period Exclusion Criteria Allergy to vancomycin Pre-existing advanced malignancies Pregnancy or Lactation Inability to provide consent 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. Current biliary obstruction Active infection Involvement in any other investigational study

Facility Information:

Facility Name

Ochsner Medical Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

12. IPD Sharing Statement

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Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

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