Xolair Treatment for Milk Allergic Children

NCT00968110 | Completed Early Phase 1 DMC

• 1 other identifier: Milk-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 allergic reactions that occur during the course of the study.

Conditions

Milk Allergy

Keywords

Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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

  week 53

Study Arms (1)

Xolair

EXPERIMENTAL

All patients will receive Xolair treatment for 16 weeks.

Drug: omalizumab

Interventions

omalizumab DRUG

Dosing table established for omalizumab

Also known as: Xolair

Xolair

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Stanford University: collaborator

Study Sites (2)

Stanford Uneiversity Medical Center

Stanford, California, 94305, United States

Location

Children's Hosptial Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Bedoret D, Singh AK, Shaw V, Hoyte EG, Hamilton R, DeKruyff RH, Schneider LC, Nadeau KC, Umetsu DT. Changes in antigen-specific T-cell number and function during oral desensitization in cow's milk allergy enabled with omalizumab. Mucosal Immunol. 2012 May;5(3):267-76. doi: 10.1038/mi.2012.5. Epub 2012 Feb 8.

  PMID: 22318492 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Dale Umetsu, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Pediatrics, Harvard Medical School

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

US (2)