A Safety and Efficacy Study of Xolair in Peanut Allergy
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Ages Eligible for Study:
6 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patient has a diagnosis of acute peanut allergy
The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
The patient is six to 75 years of age
The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
The patient is able to swallow capsules
Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
Have a history of allergy to wheat protein
Have previously been exposed to monoclonal antibody treatment