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

Roche

Status and phase: Completed; Phase 1

Conditions: Cytomegalovirus Infections, Heart Transplantation

Treatments: Drug: valganciclovir [Valcyte]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01165580

2010-021172-28

NP22523

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: Under 124 days old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: valganciclovir [Valcyte]