NCT00090766

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 3 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	valganciclovir [Valcyte]	po daily (dose based on body surface area and CrCL)

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2004-09-06
• Last updated: 2016-10-31
• Results posted: 2016-10-31

Locations

17 sites across 7 countries: United States, Australia, Canada, France, Germany, Mexico, Spain