NCT01328886

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

An Extension Study to CIGE025B1301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese Children (6 - 15 Years) With Inadequately Controlled Allergic Asthma Despite Current Recommended Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	Omalizumab	omalizumab lyophilized 150 mg injection

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-04-05
• Last updated: 2016-11-18

Locations

15 sites across 1 country: Japan