Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

NCT ID: NCT03046901

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-07
• Study Completion Date: 2019-02-25

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.

Conditions

Primary Sclerosing Cholangitis; Post- Orthotopic Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vancomycin group

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.

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

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.

Interventions

Vancomycin

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.

Intervention Type: DRUG

Other Intervention Names

Vancocin

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ochsner Health System

OTHER

Sponsor Role: lead

Responsible Party

Shamita Shah

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ochsner Medical Center

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

Pro00013111

Identifier Type: -

Identifier Source: org_study_id