NP22523-Pharmacokinetics and safety of valganciclovir in pediatric heart transplant recipients less than 4 months of age.
This is a multi-center, non-comparative, open-label study. Selected patients at risk of developing CMV disease and who are already receiving or will receive CMV preventative therapy with either i.v. ganciclovir. or valganciclovir for oral solution will have their existing treatment regimen interrupted for 2 days in order to participate in the study. In brief, patients who are receiving or are eligible to receive either i.v. ganciclovir or valganciclovir powder for oral solution (standard of care) for prevention of CMV will undergo screening for study enrollment within 2 days prior to study drug administration. Patients will have their standard of care therapy interrupted for 2 days at any time during therapy (as long as they remain within the age group criteria on the day of PK sampling), during which they will be administered oral valganciclovir once daily for 2 days. Oral valganciclovir will be dosed according to the algorithm: Oral Valganciclovir Dose (mg) = 7 x BSA x CrCLS. Blood samples will be collected for population pharmacokinetic analysis. The study-endpoints for each participating patient are defined as the time at which all study assessments and post-treatment safety follow-up, have been completed, or the time of withdrawal of consent if this occurs earlier. The end of the study, for the entire study, is defined as the time at which the last patient completes their last visit assessment.
A patient may be included if the answer to all of the following statements is
1. Parent or guardian of patient is willing and able to give written informed consent
2. Patient has received a first heart transplant.
3. Males or females aged between birth and < 4 months (<125 days) at the time of the last of PK
assessment according to the changes made in the Protocol.
4. Patient is considered to be hemodynamically stable.
5. Patient is at risk of developing CMV disease and is being treated with i.v. ganciclovir
or oral valganciclovir for prevention of CMV.
6. Patient has adequate hematological and renal function defined as:
* Absolute neutrophil count (ANC) >1.3 x 109 cells/L (1300 cells/[MICRO-SYMBOL]L)
* Platelet count >40 x 109 cells/L (>40,000 cells/[MICRO-SYMBOL]L)
* Hemoglobin >80g/L (>8.0 g/dL)
* Estimated creatinine clearance (CrCLS) of >15 mL/min/1.73m2
7. Patient is able to tolerate oral medication (any appropriate form of tube feeding is acceptable).