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Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03046901
Recruitment Status : Withdrawn (0 subjects enrolled)
First Posted : February 8, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Shamita Shah, Ochsner Health System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Post- Orthotopic Liver Transplantation Drug: Vancomycin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients
Actual Study Start Date : December 7, 2016
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : February 25, 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Other Name: Vancocin


Outcome Measures
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Primary Outcome Measures :
  1. Liver Function Test [ Time Frame: 12 weeks ]
    Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)


Secondary Outcome Measures :
  1. Liver Function Test [ Time Frame: 1 year ]
    Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)

  2. Liver Function Test [ Time Frame: 1 year ]
    Bilirubin


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046901


Locations
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United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Sponsors and Collaborators
Ochsner Health System
More Information
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Responsible Party: Shamita Shah, Principal Investigator, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03046901    
Other Study ID Numbers: Pro00013111
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Shamita Shah, Ochsner Health System:
Vancomycin
Primary Sclerosing cholangitis
Post-liver transplantation
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
 Digestive System Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents