Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
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.