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| Sponsor: | Children's Hospital Boston |
|---|---|
| Information provided by: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01290913 |
Purpose
This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.
| Condition | Intervention | Phase |
|---|---|---|
|
Peanut Allergy |
Other: omalizumab, oral desensitization |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Xolair Enhances Oral Desensitization in Peanut Allergic Patients |
| Estimated Enrollment: | 11 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| omalizumab, oral desensitization |
Other: omalizumab, oral desensitization
omalizumab given subcutaneously, every 2-4 wks for 19 wks
Other Name: Xolair
|
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.
Eligibility| Ages Eligible for Study: | 7 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Due to the risk of serious systemic anaphylactic reactions to peanut in this study, we will exclude:
Contacts and Locations| Contact: Timothy Harrington | 617-355-6127 | timothy.harrington@childrens.harvard.edu |
| United States, Massachusetts | |
| Children's Hospital Boston, Harvard Medical School | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Timothy Harrington | |
| Principal Investigator: | Dale T Umetsu, MD, PhD | Children's Hospital, Harvard Medical School |
| Study Director: | Lynda Schneider, MD | Children's Hospital, Harvard Medical School |
More Information
| Responsible Party: | Dale T. Umetsu, MD, PhD, Children's Hospital Boston, Harvard Medical School, |
| ClinicalTrials.gov Identifier: | NCT01290913 History of Changes |
| Other Study ID Numbers: | CHB10090470, Xolair and Peanut Allergy |
| Study First Received: | February 4, 2011 |
| Last Updated: | February 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
peanut allergy Xolair |
|
Hypersensitivity Peanut Hypersensitivity Immune System Diseases Food Hypersensitivity Hypersensitivity, Immediate Omalizumab |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |