Xolair Treatment for Milk Allergic Children
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.
Children's Hospital Boston has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Xolair (Omalizumab) Enhances Oral Tolerance Induction in Milk Allergic Children|
- The major goal of this study is to assess the safety of Xolair in young children, and the safety of oral desensitization in patients pretreated with Xolair [ Time Frame: week 53 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
All patients will receive Xolair treatment for 16 weeks.
Dosing table established for omalizumab
Other Name: Xolair
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968110
|United States, California|
|Stanford Uneiversity Medical Center|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Children's Hosptial Boston|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Dale Umetsu, MD||Children's Hospital Boston|