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

Primary Purpose

Varicella

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
VariZIG™
Sponsored by
Cangene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Varicella focused on measuring Immune compromised, Varicella Zoster Virus ( VZV) Infection, Pediatric

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 )

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2006
    Last Updated
    April 1, 2013
    Sponsor
    Cangene Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00338442
    Brief Title
    Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
    Official Title
    Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    December 2009 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cangene Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Varicella
    Keywords
    Immune compromised, Varicella Zoster Virus ( VZV) Infection, Pediatric

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    VariZIG™
    Intervention Description
    Biological / Vaccine

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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 )
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Gale, MD
    Organizational Affiliation
    FFF Enterprises
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33430796
    Citation
    Gans H, Chemaly RF. Varicella zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program. BMC Infect Dis. 2021 Jan 11;21(1):46. doi: 10.1186/s12879-020-05656-6.
    Results Reference
    derived
    PubMed Identifier
    31774916
    Citation
    Duchon JM, Levin MJ, Gershon AA. Safety and Varicella Outcomes in In Utero-Exposed Newborns and Preterm Infants Treated With Varicella Zoster Immune Globulin (VARIZIG): A Subgroup Analysis of an Expanded-Access Program. J Pediatric Infect Dis Soc. 2020 Sep 17;9(4):449-453. doi: 10.1093/jpids/piz070.
    Results Reference
    derived

    Learn more about this trial

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

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