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A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

Primary Purpose

Peanut Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
omalizumab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring TOPS, Peanut allergy, Peanut-induced allergy, Allergy

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completion of last visit (or early termination visit, if applicable) for Study Q2788g
  • Signed Informed Consent Form
  • Use of an effective method of contraception for females of childbearing potential
  • Body weight ≥ 20 kg and ≤ 150 kg
  • IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)

Exclusion Criteria:

  • Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36)
  • Current participation in another investigational study
  • Pregnancy or lactation
  • History of brittle asthma
  • Aspirin-sensitive asthma
  • Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20)
  • Have a polymorrphonuclear count <1500/uL
  • Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine
  • Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer)
  • Thrombocytopenia as evidenced by a platelet count < 100,000/uL
  • Any systemic condition requiring regular administration of an immunoglobulin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Serious Adverse Events
    All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator

    Secondary Outcome Measures

    Food Allergen Exposure, Assessed on Patient-reported Questionnaire
    Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
    Food-allergic Reactions As Assessed by the Ewan Scale
    The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
    Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
    All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.

    Full Information

    First Posted
    September 26, 2006
    Last Updated
    November 12, 2009
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00382148
    Brief Title
    A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
    Official Title
    A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peanut Hypersensitivity
    Keywords
    TOPS, Peanut allergy, Peanut-induced allergy, Allergy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    omalizumab
    Intervention Description
    SC repeating dose
    Primary Outcome Measure Information:
    Title
    Serious Adverse Events
    Description
    All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator
    Time Frame
    Through Week 52
    Secondary Outcome Measure Information:
    Title
    Food Allergen Exposure, Assessed on Patient-reported Questionnaire
    Description
    Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)."
    Time Frame
    Every 4 weeks through Week 52
    Title
    Food-allergic Reactions As Assessed by the Ewan Scale
    Description
    The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator
    Time Frame
    Through Week 52
    Title
    Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
    Description
    All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs.
    Time Frame
    Through Week 52

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completion of last visit (or early termination visit, if applicable) for Study Q2788g Signed Informed Consent Form Use of an effective method of contraception for females of childbearing potential Body weight ≥ 20 kg and ≤ 150 kg IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE < 30 IU/mL will be dosed at the lowest level on the dosing table [30 IU/mL], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.) Exclusion Criteria: Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36) Current participation in another investigational study Pregnancy or lactation History of brittle asthma Aspirin-sensitive asthma Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20) Have a polymorrphonuclear count <1500/uL Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer) Thrombocytopenia as evidenced by a platelet count < 100,000/uL Any systemic condition requiring regular administration of an immunoglobulin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis Wong, M.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

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