- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046901
Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients
March 27, 2019 updated by: Shamita Shah, Ochsner Health System
Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver Function Test
Time Frame: 12 weeks
|
Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Liver Function Test
Time Frame: 1 year
|
Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)
|
1 year
|
Liver Function Test
Time Frame: 1 year
|
Bilirubin
|
1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2016
Primary Completion (Actual)
February 25, 2019
Study Completion (Actual)
February 25, 2019
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 7, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2019
Last Update Submitted That Met QC Criteria
March 27, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00013111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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