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

NCT01328886 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-11-18

No results posted yet for this study

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

DRUG

Omalizumab

omalizumab lyophilized 150 mg injection

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
2011-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

More Related Trials

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 NCT01328886 on ClinicalTrials.gov