Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

Primary Sclerosing Cholangitis Clinical Trial

Official title:

Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03046901
• Other study ID #: Pro00013111
• Status: Withdrawn
• Phase: N/A
• Start date: December 7, 2016
• Est. completion date: February 25, 2019

Study information

• Verified date: March 2019
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Post- Orthotopic Liver Transplantation
• Primary Sclerosing Cholangitis

Intervention

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.

Locations

Country	Name	City	State
United States	Ochsner Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Function Test	Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)	12 weeks
Secondary	Liver Function Test	Alkaline Phosphatase (ALKP) +/- Alanine Transaminase (ALT)	1 year
Secondary	Liver Function Test	Bilirubin	1 year