Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Overview

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.

Full Title of Study: “Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 25, 2019

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Liver Function Test
    • Time Frame: 12 weeks
    • Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

Secondary Measures

  • Liver Function Test
    • Time Frame: 1 year
    • Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)
  • Liver Function Test
    • Time Frame: 1 year
    • Bilirubin

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ochsner Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shamita Shah, Principal Investigator – Ochsner Health System

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.