Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338442
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2013-04-04
First Post:
2006-06-15
Brief Title:
Safety and Efficacy of Varicella Zoster Immune Globulin Human VariZIG in Patients at Risk of Varicella Infection
Sponsor:
Cangene Corporation
Organization:
Cangene Corporation
Study Overview
Official Title:
Safety and Efficacy of Varicella Zoster Immune Globulin Human VariZIG in Patients at Risk of Varicella Infection
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2013-04
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:
This study is to assess VariZIG for the treatment of patients at risk for developing serious complications from chicken pox
Detailed Description:
In most individuals chicken pox or varicella zoster VZV infections are benign however in certain at-risk populations such as immunocompromised patients or infants VZV disease can produce significant morbidity and mortality In such patients varicella zoster immune globulin VZIG has been used to prevent or reduce the severity of VZV infections in at-risk patients exposed to individuals with active infections Massachusetts Public Health Biologic Laboratories Boston MA has discontinued manufacture of the only FDA approved VZIG product Cangene Corporation Winnipeg Canada is conducting this expanded access IND protocol for VariZIG which is a purified human immune globulin preparation made from plasma of donors with high anti-varicella antibody titers
This study is an open label non-randomized expanded access study that will make VariZIG available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted The study will begin recruiting in February 2006 and will collect safety and basic efficacy data over 42 days following VariZIG administration Physicians will be required to assess measures of varicella infection as well as provide study specific documentation
This study is an open label non-randomized expanded access study that will make VariZIG available to eligible patients for whom there is no alternative licensed treatment while a pivotal study is conducted The study will begin recruiting in February 2006 and will collect safety and basic efficacy data over 42 days following VariZIG administration Physicians will be required to assess measures of varicella infection as well as provide study specific documentation
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