Status:
APPROVED_FOR_MARKETING
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
Lead Sponsor:
Cangene Corporation
Conditions:
Varicella
Eligibility:
All Genders
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 signific...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Cangene Corporation VariZIG™ release requirement.
- Any of the following at-risk patients exposed to varicella within the previous 96 hours:
- Immunocompromised pediatric or adult patients.
- Neonates (less than 1 year of age) and pre-term infants.
- Pregnant women.
- Newborns whose mothers had VZV infection shortly before delivery (\< 5 days) or after (\< 2 days) delivery.
- Healthy non-immune adults
Exclusion
- Hypersensitivity to blood or blood products, including intravenous (IV) or intramuscular (IM) human immunoglobulin preparations.
- Selective immunoglobulin A (IgA) deficiency.
- Evidence of VZV infection.
- Evidence of zoster infection.
- Known immunity to VZV(previous varicella infection or varicella vaccination)
- Severely thrombocytopenic ( platelets \< 50 x 10x9 / L )
Key Trial Info
Start Date :
February 1 2006
Trial Type :
EXPANDED_ACCESS
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00338442
Start Date
February 1 2006
End Date
December 1 2009
Last Update
April 4 2013
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