UMIN ID: UMIN000014272
Registered date:16/06/2014
Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Wheat allergy |
| Date of first enrollment | 2014/06/02 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Subcutaneous injection of 150 mg of Omalizumab (Novartis Pharma, Japan) once every four weeks, 3 times in all. |
Outcome(s)
| Primary Outcome | To evaluate the sensitization status before and after the therapy using basophil activation test, specific IgE test, and enzyme-linked immunosorbent assay. |
|---|---|
| Secondary Outcome | Food challenge test before and after the treatment if available. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who had been administrated of Omalizumab in history, and patients who receive immunosuppressive drugs. |
Related Information
| Primary Sponsor | Shimane University Hospital |
|---|---|
| Secondary Sponsor | Fujita Health University Tokyo Medical and Dental University Osaka University Hiroshima University Hyogo Prefectural Kakogawa Medical Center National Hospital Organization, Sagamihara National Hospital National Hospital Organization, Fukuoka National Hospital |
| Source(s) of Monetary Support | Research Center for Prevention of Lifestyle-Related Disease,Yuuka Co., Ltd. KATAYAMA CHEMICAL, INC PHOENIX Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuko Chinuki |
| Address | Enya 89-1, Izumo, Shimane 693-8501, Japan Japan |
| Telephone | 0853-20-2210 |
| ychinuki@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Hospital Dermatology |
| scientific contact | |
| Name | Yuko Chinuki |
| Address | Enya 89-1, Izumo, Shimane 693-8501, Japan Japan |
| Telephone | 0853-20-2210 |
| ychinuki@med.shimane-u.ac.jp | |
| Affiliation | Shimane University Hospital Dermatology |