Wheat allergy
Conditions
Interventions
1. Generic name: Omalizumab
trade name: Xolair for s.c. ingection 75mg/V or 150mg/V (Novartis Pharma, Japan). 2. Start the treatment protocol within 4 weeks of entry. Administration dose and intervals of Omalizumab are calculat
Sponsors
Shimane University Hospital
Fujita Health University National Hospital Organization, Sagamihara National Hospital National Hospital Organization, Fukuoka National Hospital Tokyo Medical and Dental University Osaka University Hiroshima University Hyogo Prefectural Kakogawa Medical Center Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. More than 20 years old male and female. 2. Patients who meet the diagnostic criteria of immediate-type wheat allergy induced by GP19S made by Special Committee for Japanese Society for Allergology; Patient who meet the diagnostic criteria of wheat-dependent exercise-induced anaphylaxis made by study group of Guideline for the treatment of life-threatening food allergy, supported by Health and Labor Sciences Research Grant; Patients who had an allergic reaction to wheat within one year or patients who avoid wheat ingestion because of the high titer of serum wheat-specific IgE. 3. Those who can visit doctor's office every 2 to 4 weeks. 4. Those who can sign the treatment consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have hypersensitivity to ingredients of Omalizumab (Novartis Pharma, Japan). 2. Patients who receive immunosuppressive drugs. 3. Patients with decompensated liver cirrhosis. 4. Patients with severe kidney disease; more than 2.0mg/dL of serum creatinine level within 4 weeks prior to the entry. 5. Patients with liver disease, psychiatric disorder, convulsive seizure and seizure disorder, cardiovascular disease, abnormal hemoglobin disease, hemophilia, and autoimmune disease. 6. Pregnant women, breast-feeding women, and women suspected of being pregnant. 7. Patients ineligible for the clinical trial at a physician's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reactivity below 10% to wheat allergen in basophil activation test using peripheral blood after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of 0 score in wheat-challenge test after the treatment. | — |
Countries
Japan
Contacts
Public ContactYuko Chinuki
Shimane University Hospital Dermatology
Outcome results
None listed