drugset / Trial / NCT03046901

Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

NCT03046901

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2016-12-07
Primary completion
2019-02-25
Completion
2019-02-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified 500 mg Oral