Xolair Treatment for Milk Allergic Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00968110|
Recruitment Status : Active, not recruiting
First Posted : August 28, 2009
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Milk Allergy||Drug: omalizumab||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Xolair (Omalizumab) Enhances Oral Tolerance Induction in Milk Allergic Children|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||July 2018|
All patients will receive Xolair treatment for 16 weeks.
Dosing table established for omalizumab
Other Name: Xolair
- 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 ]
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): 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||Boston Children’s Hospital|