NCT00338442

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

3.8 years

First QC Date

June 15, 2006

Last Update Submit

April 1, 2013

Conditions

Varicella

Keywords

Immune compromisedVaricella Zoster Virus ( VZV) InfectionPediatric

Interventions

VariZIG™DRUG

Biological / Vaccine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33430796DERIVED

  • 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.

    PMID: 31774916DERIVED

MeSH Terms

Conditions

ChickenpoxInfections

Interventions

varicella-zoster immune globulin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus Diseases

Study Officials

  • Robert Gale, MD

    FFF Enterprises

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 20, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 4, 2013

Record last verified: 2013-04