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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01165580

Enrollment

Registered

2010-07-20

Start date

2011-05-31

Completion date

2013-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infections, Heart Transplantation

Brief 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.

Interventions

DRUGvalganciclovir [Valcyte]

oral dose, Days 1 and 2

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 124 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Peak concentration of ganciclovir	0, 1-3, 3-7, 7-12, 24 hours post-dose
Area under plasma concentration versus time curve of ganciclovir	0, 1-3, 3-7, 7-12, 24 hours post-dose
Apparent volume of distribution of ganciclovir	0, 1-3, 3-7, 7-12, 24 hours post-dose
Terminal half-life of ganciclovir	0, 1-3, 3-7, 7-12, 24 hours post-dose

Secondary

Measure	Time frame
Safety (Incidence of adverse events)	9 days

Countries

Canada, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026