IVIG - West Nile Encephalitis: Safety and Efficacy
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This study will look at the safety and effectiveness of an experimental medication containing
antibodies (Omr-IgG-am™) in people with West Nile Virus (WNV) who already have brain and/or
spinal cord inflammation or who are at high risk of developing these problems because they
have weak immune systems. WNV can cause problems such as headaches, fever, muscle weakness,
coma, and death. Study investigators believe people who are not able to fight infection well
may be at risk for developing neurologic problems (having to do with the brain, spinal cord,
nerves, and muscles) if they get WNV infection. Up to 110 subjects, 18 years or older, will
participate for about 3 months and will receive either Omr-IgG-am™, Polygam® S/D, or placebo
given through a small tube placed in a blood vessel in the arm. Hospitalization, up to 5
additional study visits, blood sample collection, MRI pictures of the brain and spinal cord,
and neurological, muscle, and heart activity tests are also required.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Antibodies gamma-Globulins Immunoglobulin G Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin