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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382148
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Information provided by:
Genentech, Inc.

September 26, 2006
September 28, 2006
November 5, 2009
December 15, 2009
December 15, 2009
November 2006
June 2008   (Final data collection date for primary outcome measure)
Serious Adverse Events [ Time Frame: Through Week 52 ]
The primary outcome measure is serious adverse events.
Complete list of historical versions of study NCT00382148 on Archive Site
  • Food Allergen Exposure, Assessed on Patient-reported Questionnaire [ Time Frame: Every 4 weeks through Week 52 ]
  • Food-allergic Reactions As Assessed by the Ewan Scale [ Time Frame: Through Week 52 ]
  • Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs [ Time Frame: Through Week 52 ]
  • Food-allergen exposure assessed using a subject-reported, food-related allergic event questionnaire
  • Food-allergic reactions as assessed by the Ewan scale
  • Nonserious food-related adverse events
  • Other nonserious adverse events.
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A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peanut Hypersensitivity
Drug: omalizumab
SC repeating dose
Experimental: 1
Intervention: Drug: omalizumab
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 75 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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Clinical Trials Posting Group, Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Dennis Wong, M.D. Genentech, Inc.
Genentech, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP