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The purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in Japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | omalizumab lyophilized 150 mg injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs | Every 3 months for approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the efficacy of omalizumab by JPAC questionnaire; JPAC is the Japan Pediatric Asthma Control Program (JPAC) | Every 3 months for approximately 2 years | |
| To explore the efficacy of omalizumab by QOL questionnaire score (Quality of life questionnaires for pediatric patients with bronchial asthma and their parents or caregivers (Gifu)) |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 27507228 | Derived | Odajima H, Ebisawa M, Nagakura T, Fujisawa T, Akasawa A, Ito K, Doi S, Yamaguchi K, Katsunuma T, Kurihara K, Teramoto T, Sugai K, Nambu M, Hoshioka A, Yoshihara S, Sato N, Seko N, Nishima S. Long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with severe uncontrolled asthma. Allergol Int. 2017 Jan;66(1):106-115. doi: 10.1016/j.alit.2016.06.004. Epub 2016 Aug 6. |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Every 3 months for approximately 2 years |
| To explore the efficacy of omalizumab by use of asthma long-term control medications | Every 3 months for approximately 2 years |
| To explore the efficacy of omalizumab by Pulmonary function (FEV1, FVC, V(・)50, V(・)25 and FEF25-75%) | Every 3 months for approximately 2 years |
| To collect the data on the number of hospitalizations, emergency room (ER) visits due to asthma | Every 3 months for approximately 2 years |
| 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 | 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 | 158-0097 | Japan |
| Novartis Investigative Site | Sumida-ku | Tokyo | 130-8587 | Japan |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |