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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00338442
• Other study ID #: VZ-009
• Status: Approved for marketing
• Phase: N/A
• First received: June 15, 2006
• Last updated: April 1, 2013
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: April 2013
• Source: Cangene Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 )

Study Design

N/A

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Drug:
• VariZIG™
Biological / Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cangene Corporation