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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:8/3/2016
Start Date:May 2011
End Date:September 2013

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Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age

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.


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
We found this trial at
17
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Milwaukee, WI
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Charleston, South Carolina 29412
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Edmonton,
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Seattle, WA
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