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

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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
  Purpose

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


Condition Intervention
Varicella
Drug: VariZIG™

Study Type: Expanded Access     What is Expanded Access?
Official Title: Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection

Resource links provided by NLM:


Further study details as provided by Cangene Corporation:

Study Start Date: February 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: VariZIG™
    Biological / Vaccine
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 )
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338442

Sponsors and Collaborators
Cangene Corporation
Investigators
Principal Investigator: Robert Gale, MD FFF Enterprises
  More Information

No publications provided

Responsible Party: Cangene Corporation
ClinicalTrials.gov Identifier: NCT00338442     History of Changes
Other Study ID Numbers: VZ-009
Study First Received: June 15, 2006
Last Updated: April 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cangene Corporation:
Immune compromised
Varicella Zoster Virus ( VZV) Infection
Pediatric

Additional relevant MeSH terms:
Herpes Zoster
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antibodies
Immunoglobulins
Immune Sera
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014