Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children

Summary

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.

Timeline

Start

2011-03

Primary completion

2013-12

Completion

2013-12

Publications

• 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.

Drugs

Indications