Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098046
Status:
COMPLETED
Last Update Posted:
2007-09-26
First Post:
2004-12-02
Brief Title:
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Pharmacokinetics and Safety of Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Varicella zoster virus causes chickenpox in children and shingles in adults Chickenpox is usually a self-limiting illness characterized by fever and a rash Serious complications can include secondary bacterial infections pneumonia and encephalitis Anti-viral treatment is not a standard of care in immunocompetent children but is recommended whenever a risk of complication exists This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age
Detailed Description:
None
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