Status:
COMPLETED
Xolair Treatment for Milk Allergic Children
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Stanford University
Conditions:
Milk Allergy
Eligibility:
All Genders
4-18 years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
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 or...
Eligibility Criteria
Inclusion
- Moderate to severe pediatric cow's milk allergy-sensitive subjects between the ages of 4-18 years old.
- Total IgE \>30 kU/L
- Sensitivity to cow's milk allergen will be documented by a positive skin prick test result (see Appendix E for details) and RAST test to cow's milk, with 25 kU/L as a lower limit of eligibility. Patients who do not meet the cow's milk RAST requirement may be eligible for this study if they have a history of a moderate to severe reaction, and if they have recently failed an oral food challenge with milk ordered by their physician.
- All female subjects of child-bearing potential will be required to provide a urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
- Subjects must be planning to remain in the study area during the trial.
- Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study.
Exclusion
- No absolute contraindications to allergen skin testing and/or oral ingestion of milk are known. However, the risk of serious systemic anaphylactic reactions to milk suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
- Subjects having a history of severe anaphylaxis to milk requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
- Total IgE \> 2000 IU/mL.
- Subjects with unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that in the mind of the investigator might interfere with the evaluation or administration of the test drug or pose additional risk to the subject e.g. gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
- Subject with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, the oral desensitization visit, or food challenge visit.
- Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study.
- Subjects who are current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical).
- Subjects routinely using medication that could induce adverse gastrointestinal reactions during the study.
- Subjects refusing to sign the EpiPen Training Form (see Appendix F).
- Pregnant or breast feeding females.
- Subjects with a history of rice and soy allergy.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00968110
Start Date
March 1 2009
End Date
April 1 2017
Last Update
October 2 2018
Active Locations (2)
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1
Stanford Uneiversity Medical Center
Stanford, California, United States, 94305
2
Children's Hosptial Boston
Boston, Massachusetts, United States, 02115