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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Xolair (omalizumab)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Moderate Persistent Asthma, Severe Persistent Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2005
    Last Updated
    June 19, 2013
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00109187
    Brief Title
    An Extension Study of Xolair in Moderate to Severe, Persistent Asthma Patients Who Completed Study Q2143g
    Official Title
    Open-Label Extension Study II of Xolair (Omalizumab) in Moderate to Severe, Persistent Asthma Subjects Who Completed Study Q2143g (ALTO)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Moderate Persistent Asthma, Severe Persistent Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    None (Open Label)
    Enrollment
    0 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Xolair (omalizumab)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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