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Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)

2014-08-27 03:12:29 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Allergic Asthma

Intervention

omalizumab

Location

Novartis Investigative Site
Ohbu
Aichi
Japan
474-0031

Status

Completed

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:29-0400

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