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The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults and children, and assess efficacy and safety data in Japanese pediatric patients which will fulfill the Japanese health authority requirement for approval. Data obtained from the study is intended to be used to support the registration of pediatric indication of omalizumab in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Omalizumab treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients reaches under 25 ng/mL (target level). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess PK/PD data by modeling & simulation | 24 weeks | |
| To assess the efficacy of omalizumab by PEF, pulmonary function, asthma symptom score, asthma rescue medication use and QOL questionnaire score. | 24 weeks |
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Inclusion Criteria:
Asthma symptoms every day; Night-time symptoms in â¥2 out of the last 14 days (missing data to be treated as a day with no symptoms); Limitation of daily activities in â¥2 out of the last 14 days (missing data to be treated as a day with no limitations)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ohbu | Aichi-ken | 474-0031 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26433533 | Result | Odajima H, Ebisawa M, Nagakura T, Fujisawa T, Akasawa A, Ito K, Doi S, Yamaguchi K, Katsunuma T, Kurihara K, Kondo N, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Omalizumab in Japanese children with severe allergic asthma uncontrolled with standard therapy. Allergol Int. 2015 Oct;64(4):364-70. doi: 10.1016/j.alit.2015.05.006. Epub 2015 Jun 10. |
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| To assess the safety of omalizumab | 24 weeks |
| Chiba |
| Chiba |
| 266-0007 |
| Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-1394 | Japan |
| Novartis Investigative Site | Gifu | Gifu | 501-1194 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 228-8522 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232-8555 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 245-8575 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-0125 | Japan |
| Novartis Investigative Site | Tenri | Nara | 632-8552 | Japan |
| Novartis Investigative Site | Habikino | Osaka | 583-8588 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 530-0012 | Japan |
| Novartis Investigative Site | Shimotsuka-gun | Tochigi | 321-0293 | Japan |
| Novartis Investigative Site | Fuchū | Tokyo | 183-8561 | Japan |
| Novartis Investigative Site | Komae | Tokyo | 201-8601 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 158-0097 | Japan |
| Novartis Investigative Site | Sumida-ku | Tokyo | 130-8587 | Japan |
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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