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Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

This treatment has been approved for sale to the public.
Sponsor:
Information provided by (Responsible Party):
Cangene Corporation
ClinicalTrials.gov Identifier:
NCT00338442
First received: June 15, 2006
Last updated: April 1, 2013
Last verified: April 2013

June 15, 2006
April 1, 2013
February 2006
December 2009   (final data collection date for primary outcome measure)
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To assess the safety and efficacy of VariZIG™ in the prevention or reduction of complications resulting from varicella zoster virus (VZV) infections in at-risk patients exposed to individuals with infectious VZV infections.
Complete list of historical versions of study NCT00338442 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.

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.

Expanded Access
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Varicella
Drug: VariZIG™
Biological / Vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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 )
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00338442
VZ-009
No
Cangene Corporation
Cangene Corporation
Not Provided
Principal Investigator: Robert Gale, MD FFF Enterprises
Cangene Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP