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Xolair Enhances Oral Desensitization in Peanut Allergic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dale T Umetsu, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01290913
First received: February 4, 2011
Last updated: January 16, 2013
Last verified: January 2013

February 4, 2011
January 16, 2013
February 2011
January 2013   (final data collection date for primary outcome measure)
ability of a patient to tolerate rapid oral peanut desensitization to a dose of 500 mg peanut (cumulative dose, 1,000 mg). [ Time Frame: First day of desensitization ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01290913 on ClinicalTrials.gov Archive Site
ability of a patient to tolerate rapid oral peanut desensitization to a dose of 4,000 mg of peanut. [ Time Frame: after 7-8 wks of desensitization ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Xolair Enhances Oral Desensitization in Peanut Allergic Patients
Xolair Enhances Oral Desensitization in Peanut Allergic Patients

This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.

We hypothesize that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to peanut and will enhance the development of oral tolerance in patients with severe peanut allergy.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peanut Allergy
Drug: Omalizumab
Experimental: omalizumab, oral desensitization
Intervention: Drug: Omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
11
September 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with severe peanut allergy, between the ages of 7-25 years, having a history of significant clinical symptoms within 1 hr of peanut ingestion.
  2. Total IgE >50 kU/L but <2,0000 kU/L.
  3. Sensitivity to peanut will be documented by a positive skin prick test result and RAST test to peanut, with 20 kU/L as a lower limit for eligibility.
  4. Patients must also fail a double blind food challenge with peanut at a dose of 100 mg or less (after a cumulative dose of 186 mg), with minimal or no reactions to the placebo challenge.
  5. All female subjects of childbearing 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.
  6. Subjects must be planning to remain in the study area during the trial.
  7. 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 Criteria:

Due to the risk of serious systemic anaphylactic reactions to peanut in this study, we will exclude:

  1. Patients with acute infections, autoimmune disease, severe cardiac disease, and those who are treated with beta-adrenergic antagonistic drugs (beta-blockers, which increase the risk of more serious symptoms of anaphylaxis).
  2. Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent urticaria, or history consistent with poorly controlled persistent asthma.
  3. Total IgE > 2,000 IU/mL.
  4. 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.
  5. Subject with an FEV1 or PEF less than 80% predicted with or without controller medication (if able to perform the maneuver) at screening, the oral desensitization visit, or food challenge visit.
  6. 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, who are current users of oral, intramuscular, or intravenous corticosteroids, or tricyclic antidepressants, or who are using medication that could induce adverse gastrointestinal reactions during the study.
  7. Subjects refusing to sign the EpiPen Training Form.
  8. Pregnant or breast-feeding females.
  9. Subjects with severe food associated eczema, dermatitis herpetiformis, eosinophilic esophagitis, eosinophilic enteritis, proctocolitis, food protein induced enterocolitis syndrome (FPIES) or other gastrointestinal diseases. These requirements are necessary to limit the study to patients with primarily IgE mediated peanut allergy, and to exclude patients with peanut sensitivity mediated by cellular/T cell (non-IgE mediated) mechanisms.
Both
7 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01290913
CHB10090470, Xolair and Peanut Allergy
Yes
Dale T Umetsu, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Dale T Umetsu, MD, PhD Children's Hospital, Harvard Medical School
Study Director: Lynda Schneider, MD Children's Hospital, Harvard Medical School
Children's Hospital Boston
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP