日本人小児（6～15歳）におけるオマリズマブの薬物動態および薬力学、有効性および安全性

基本情報

NCT ID

NCT01155700

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

51

治験依頼者名

Novartis

概要

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.

対象疾患

介入

依頼者（Sponsor）