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

Phase 1

Completed

• Conditions: Cytomegalovirus Infections, Heart Transplantation
• Interventions: Drug: valganciclovir [Valcyte]

• Registration Number: NCT01165580
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-20
• Study Start: 2011-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	valganciclovir [Valcyte]	-

Primary Outcome Measures

Name	Time	Method
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
Peak concentration of ganciclovir	0, 1-3, 3-7, 7-12, 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Safety (Incidence of adverse events)	9 days