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This is an open label trial of mouse allergenic extract administered by subcutaneous injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:
- the safety of this therapy when given by injection
- biomarkers of the immune response and
- whether the therapy would be effective in treating allergic asthma.
The primary objective of the study is to assess if treatment with mouse subcutaneous immunotherapy (SCIT), using the per protocol allergenic extract doses, is safe. This will be done by determining the rate of related adverse events and serious adverse events in the course of treatment.
Secondary objectives include:
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol allergenic extract doses, will induce a 3-fold increase in mouse-specific serum immunoglobulin E (IgE)
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol allergenic extract doses, will induce changes in the serum levels of mouse-specific IgG and IgG4.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Mouse Allergenic Extract
Children's National Health System
District of Columbia
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2015-08-25T22:08:22-0400
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