drugset / Trial / NCT00730769

Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

NCT00730769

Phase 4 Completed 21 enrolled Salvador Gil-Vernet Roche Pharma AG · collab
NaSingle-groupOpen-labelTreatment

Summary

The objectives of this study were: 1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment. 2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.). 3. Evaluate the security of this treatment with valganciclovir.

Timeline

Start
2004-03
Primary completion
2007-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganciclovir Small molecule 5 mg/kg Intravenous
Subject Valganciclovir Small molecule 900 mg Oral