Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001100
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
1999-11-02
Brief Title:
A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir Dihydroxypropoxymethyl Guanine DHPG Treatment of Symptomatic Central Nervous System CNS Congenital Cytomegalovirus CMV Infections
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 Study to Evaluate the Safety and Efficacy of Ganciclovir Dihydroxypropoxymethyl Guanine DHPG Treatment of Symptomatic Central Nervous System CNS Congenital Cytomegalovirus CMV Infections
Status:
COMPLETED
Status Verified Date:
2005-11
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 the benefits and safety of the antiviral drug ganciclovir DHPG given intravenously to treat newborn infants who are born infected with cytomegalovirus CMV CMV is a herpes virus that can infect most organs of the body resulting in death in 10-30 of babies with symptoms of CMV It can cause severe brain damage in a large percentage of surviving babies Children in this study have a CMV infection of the central nervous system CNS
Detailed Description:
The study will enroll 130 newborn infants 1 month of age or younger with CMV involving the CNS Patients will be assigned randomly like tossing a coin to receive either DHPG or no study drug treatment All babies in the study will receive standard of care treatment and clinical diagnostic laboratory safety and follow-up evaluations Follow-up evaluations including hearing and eye exams and developmental assessments will be done periodically until the child reaches 5 years of age The degree of improved hearing among surviving patients will be a primary measure of drug effectiveness
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 |
|---|---|---|---|
| DAB-AL-558607 | None | None | None |