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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01328886
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    omalizumab lyophilized 150 mg injection

Study Details

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.

Key Dates

Start date
Mar 31, 2011
Status verified
Nov 2016
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab

Primary Outcome Measure

To assess the long-term safety and tolerability of omalizumab by measuring AEs, serious AEs, physical examination, medical history, laboratory assessments and vital signs [ Time Frame: Every 3 months for approximately 2 years ]

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