Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031434
Status:
COMPLETED
Last Update Posted:
2011-02-07
First Post:
2002-03-06
Brief Title:
Valganciclovir in Congenital CMV Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Pharmacokinetic and Pharmacodynamic Evaluation of Oral Valganciclovir in Neonates With Symptomatic Congenital Cytomegalovirus CMV Infection CASG 109
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate how ganciclovir is metabolized when administered intravenously by a needle inserted into a vein following valganciclovir syrup given by mouth to newborns and young infants with symptoms of congenital present at birth cytomegalovirus CMV disease The study also seeks to identify a dose of valganciclovir that provides a comparable blood concentration to ganciclovir present in the blood of newborns with symptomatic congenital CMV disease All study participants will receive 6 weeks of antiviral therapy defined as ganciclovir andor valganciclovir Infants from 0 to 30 days old will participate in the study for 2 years
Detailed Description:
Recent trials have demonstrated that ganciclovir treatment of neonates with symptomatic congenital cytomegalovirus CMV disease involving the central nervous system results in improved hearing function or maintenance of normal hearing function and prevents hearing deterioration at 6 months Furthermore ganciclovir therapy may prevent hearing deterioration at 1 year Ganciclovir recipients also have a more rapid resolution of their transaminase elevations and a greater degree of short term growth in weight and head circumference compared with untreated patients Valganciclovir the oral product of ganciclovir has been developed as a syrup formulation and presents the opportunity to treat longer but pharmacokinetic data are needed in infants first to assure the correct dose is being utilized This Phase III multi-center open-label trial will assess the safetytolerability and pharmacokinetics ganciclovir concentrations following administration of oral valganciclovir to neonates with symptomatic congenital CMV disease A total of 24 patients will be evaluated All patients entered into this study will receive 6 weeks 42 days of antiviral therapy defined as ganciclovir andor valganciclovir Two different dose determination strategies will be applied in this protocol The first is an individual patient approach The second is a group dose modification strategy The primary endpoint is pharmacokinetics of ganciclovir following administration of oral valganciclovir syrup The pharmacokinetics will be assessed by a population approach to PK data analysis Secondary endpoints are the pharmacokinetics of valganciclovir following administration of oral valganciclovir the correlation of ganciclovir plasma concentrations following administration of intravenous ganciclovir and oral valganciclovir syrup with CMV whole blood viral load lack of vomiting andor diarrhea associated with the administration of oral valganciclovir syrup and assessment of toxicity such as neutropenia associated with the administration of oral valganciclovir syrup
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASG 109 | None | None | None |