Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
|ClinicalTrials.gov Identifier: NCT00338442|
Recruitment Status : Approved for marketing
First Posted : June 20, 2006
Last Update Posted : April 4, 2013
|First Submitted Date||June 15, 2006|
|First Posted Date||June 20, 2006|
|Last Update Posted Date||April 4, 2013|
|Brief Title||Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection|
|Brief Summary||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.
|Study Type||Expanded Access|
Biological / Vaccine
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries||United States|
|Responsible Party||Cangene Corporation|
|Study Sponsor||Cangene Corporation|
|PRS Account||Cangene Corporation|
|Verification Date||April 2013|