CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
valganciclovir [Valcyte]drug
Likely dose
Valganciclovir po daily (dose based on body surface area and CrCL)AI-extracted
Key inclusion· 4
  • ✓Age 3 months to 16 years
  • ✓First solid organ transplant (kidney, liver, heart, etc.)
  • ✓Able to tolerate oral medication
  • ✓At risk of developing CMV disease (D-R- CMV status excluded)
Key exclusion· 4
  • ✕Prior participation in this study
  • ✕Concurrent participation in another clinical trial without Sponsor approval
  • ✕Severe, uncontrolled diarrhea (>5 watery stools per day)
  • ✕Pregnant or lactating females

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090766
NCT00090766Phase 3Completed
CompareCT.gov

Safety and Pharmacokinetics of Valganciclovir Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Hoffmann-La Roche·interventional·Posted Sep 6, 2004·Updated Oct 31, 2016

In Brief

A Phase 3 clinical trial evaluating valganciclovir [Valcyte] for Cytomegalovirus Infections. Completed, enrolled 63 participants across 17 sites in 7 countries.

Detailed Summary

This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesAustralia, Canada, France, Germany, Mexico, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 6, 2004
Enrollment StartMay 1, 2004
Primary CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 21.8 years ago

Interventions

valganciclovir [Valcyte]drug

po daily (dose based on body surface area and CrCL)