A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

• Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study

• Parent or guardian of the patient is willing and able to give written informed consent

• Patient has received a first heart transplant

• Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV

• Adequate hematological and renal function

• Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)

Exclusion Criteria:

• Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past

• Severe, uncontrolled, clinically abnormal diarrhea

• Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)

• Patient requires use of any protocol prohibited concomitant medications

• Patient has previously participated in this clinical trial