drugset / Trial / NCT00555971

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

NCT00555971

Phase 4 Completed 16 enrolled David Lang Genentech, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 24 week double-blind study in which subjects will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair injections will occur every 2-4 weeks. Aspirin desensitization will occur several weeks later. One month after desensitization, the final visit will occur in the GCRC. We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced reaction.

Timeline

Start
2006-05
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omalizumab Monoclonal antibody