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

NCT01155700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-11-18

No results posted yet for this study

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.

Conditions

  • Allergic Asthma

Interventions

DRUG

omalizumab

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01155700 on ClinicalTrials.gov