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| Sponsor: | Children's Hospital Boston |
|---|---|
| Collaborator: |
Stanford University |
| Information provided by: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00968110 |
Purpose
This is a pilot feasibility study, using Xolair pretreatment for oral milk desensitization. The major assessment will be safety, and the investigators will evaluate for any type of reaction, including allergic reactions that occur during the course of the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Milk Allergy |
Drug: omalizumab |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Xolair (Omalizumab) Enhances Oral Tolerance Induction in Milk Allergic Children |
| Estimated Enrollment: | 8 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Xolair: Experimental
All patients will receive Xolair treatment for 16 weeks.
|
Drug: omalizumab
Dosing table established for omalizumab
|
Our hypothesis is that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to foods and will enhance the development of oral tolerance in patients with severe milk allergy. Once desensitized to milk, children will be able to tolerate milk in a Double Blind Placebo Controlled Food Challenge.
The study will also evaluate whether Xolair provides a robust durability of tolerance once administration of Xolair is terminated. We will examine the specific immunological mechanisms that mediate oral tolerance in children undergoing oral milk desensitization
The trial will be conducted in three parts: (1) pre-treatment with Xolair for 8 weeks, (2) oral desensitization to cow's milk from weeks 9-16 and continued treatment with Xolair for 8 weeks, and (3) double blind placebo controlled food challenge to milk.
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Irene Borras Coughlin, CCRC | 617-355-6127 | irene.borras@childrens.harvard.edu |
| Contact: Elizabeth Hoyte, RN | 650-498-4039 | ehoyte@stanford.edu |
| United States, California | |
| Stanford Uneiversity Medical Center | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Elizabeth Hoyte, RN 650-498-4039 ehoyte@stanford.edu | |
| Sub-Investigator: Kari Nadeau, MD, PhD | |
| United States, Massachusetts | |
| Children's Hosptial Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Irene Borras Coughlin, CCRC 617-355-6127 irene.borras@childrens.harvard.edu | |
| Principal Investigator: Dale Umetsu, MD, PhD | |
| Principal Investigator: | Dale Umetsu, MD | Children's Hospital Boston |
More Information
| Responsible Party: | Children's Hospital Boston ( Dale Umetsu, MD, PhD ) |
| Study ID Numbers: | Milk-01 |
| Study First Received: | August 27, 2009 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00968110 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Milk Allergy |
|
Respiratory System Agents Hypersensitivity Food Hypersensitivity Immune System Diseases Milk Hypersensitivity Therapeutic Uses |
Hypersensitivity, Immediate Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Omalizumab |