Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004278
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase III Randomized Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
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:
OBJECTIVES
I Evaluate the efficacy of ganciclovir 12 mgkg per day versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease
I Evaluate the efficacy of ganciclovir 12 mgkg per day versus no treatment in neonates with symptomatic congenital cytomegalovirus infection with central nervous system disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified by participating institution
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks
Patients are followed at weeks 1-4 and 12 months 6 12 24 36 48 and 60 and yearly thereafter until puberty when possible
Patients are randomly assigned to no antiviral therapy or intravenous ganciclovir every 12 hours for 6 weeks
Patients are followed at weeks 1-4 and 12 months 6 12 24 36 48 and 60 and yearly thereafter until puberty when possible
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID-558607 | None | None | None |