Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00086606
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
75 Years
Study:
NCT00086606
Study Brief:
Protocol Section:
NCT00086606