Xolair Enhances Oral Desensitization in Peanut Allergic Patients
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|ClinicalTrials.gov Identifier: NCT01290913|
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : February 20, 2015
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: Omalizumab||Phase 1 Phase 2|
We hypothesize that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to peanut and will enhance the development of oral tolerance in patients with severe peanut allergy.
We will follow the patients for 5 years following study completion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Xolair Enhances Oral Desensitization in Peanut Allergic Patients|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: omalizumab, oral desensitization
Patients receive omalizumab along with oral peanut desensitization.
Omalizumab is an antibody that helps decrease allergic responses in the body
Other Name: Xolair
- Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg) [ Time Frame: First day of desensitization ]To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.
- Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour. [ Time Frame: after 7-8 wks of desensitization ]To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290913
|United States, Massachusetts|
|Children's Hospital Boston, Harvard Medical School|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Rima T Rachid, MD||Children's Hospital, Harvard Medical School|
|Study Director:||Lynda Schneider, MD||Children's Hospital, Harvard Medical School|