Viewing Study NCT00004278



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
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

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