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.
|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|
|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)|
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.