An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g

Study Overview
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Brief Summary
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This is a Phase IIIb, multicenter, open-label, extension study available to subjects who successfully complete Study Q2143g and have not participated in Study Q2195g. Subjects should be registered via the IVRS (Interactive Voice Response System) within 48 hours prior to their baseline visit. All subjects in this study will be treated with Xolair for 24 weeks. Subjects in the New Treatment Group may require additional visits for study drug injections (as frequently as every 2 weeks). Data collection during these additional visits will be limited to the assessment of adverse events. The study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.

Official Title
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Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Xolair (omalizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful completion of the 24-week study period in Study Q2143g Signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative) For subjects who have never received Xolair, a serum IgE level >=30 IU/mL and <=1300 IU/mL and have a body weight >=20 kg and <=150 kg Females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. Exclusion Criteria: Thrombocytopenia as evidenced by a platelet count of <100,000/uL Pregnant or breastfeeding Significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months History of neoplasia Any systemic condition requiring regular administration of an immunoglobulin Known hypersensitivity to any ingredients of Xolair, including excipients (sucrose, histidine, polysorbate 20) History of noncompliance with medical regimens Current participation in a study using an investigational new drug other than Xolair Participation in Study Q2195g
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xolair (omalizumab)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate Persistent Asthma, Severe Persistent Asthma