Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

Sponsor
Novartis
Study ID
NCT00482248
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

Key Dates

Start date
Jun 30, 2003
Status verified
Nov 2016
Primary completion
Jun 30, 2006
Completion
Jun 30, 2006

Study Design

Enrollment
132 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.

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