At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 325 enrolled
Drug / intervention
Ganciclovir +1 moredrug
Likely dose
Ganciclovir 5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of Oral Valcyte Versus Intravenous Ganciclovir on CMV Viremia in Solid Organ Transplant Patients
In Brief
A Phase 4 clinical trial evaluating Ganciclovir and valganciclovir [Valcyte] for Cytomegalovirus Infections. Completed, enrolled 325 participants across 50 sites in 21 countries.
Detailed Summary
This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients. Eligible patients will be randomized to receive either 1)Valcyte 900mg po bid or 2)ganciclovir 5mg/kg iv bid. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesAustralia, Austria, Belgium, Brazil, Canada, Croatia, Estonia, India, Ireland, Italy, Latvia, Mexico, New Zealand, Norway, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, Venezuela
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2004
First PostedFeb 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedFeb 5, 2007
Enrollment StartApr 1, 2004
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.4 years ago
Interventions
Ganciclovirdrug
5mg/kg iv bid for 21 days
valganciclovir [Valcyte]drug
900mg po bid for 21 days