drugset / Trial / NCT01376804

A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

NCT01376804

Phase 4 Completed 57 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelPrevention

Summary

This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte orally daily for up to 200 days post-transplant and will be followed for 52 weeks post-transplantation.

Timeline

Start
2011-07-31
Primary completion
2013-05-31
Completion
2013-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Valganciclovir Small molecule Oral