Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy

UMIN ID: UMIN000019250

Registered date:10/10/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Wheat allergy
• Date of first enrollment: 2015/09/28
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 calculated by total IgE and body weight, 75-600mg for 2-4 week interval. Duration of administrations is 44 weeks and follow-up is 24 weeks.

Outcome(s)

• Primary Outcome: Rate of reactivity below 10% to wheat allergen in basophil activation test using peripheral blood after the treatment.
• Secondary Outcome: Rate of 0 score in wheat-challenge test after the treatment.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Shimane University Hospital
• Secondary Sponsor: 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
• Source(s) of Monetary Support: Research center for prevention of lifestyle-related disease,Yuuka Co., Ltd Katayama Kogyo Co., Ltd PHOENIX Co., Ltd