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

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