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

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.

Inclusion Criteria:

• patients between 3 months and 16 years of age;
• first solid organ transplant (eg, kidney, liver, heart);
• able to tolerate oral medication;
• females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
• patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).

Exclusion Criteria:

• patients who have previously participated in this study;
• patients who are participating in another clinical trial (except with the approval of the Sponsor);
• severe, uncontrolled diarrhea (more than 5 watery stools per day);
• pregnant or lactating females.