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

This study has been completed.
Sponsor:
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00382148
First received: September 26, 2006
Last updated: November 12, 2009
Last verified: November 2009

September 26, 2006
November 12, 2009
November 2006
June 2008   (final data collection date for primary outcome measure)
Serious Adverse Events [ Time Frame: Through Week 52 ] [ Designated as safety issue: Yes ]
The primary outcome measure is serious adverse events.
Complete list of historical versions of study NCT00382148 on ClinicalTrials.gov Archive Site
  • Food Allergen Exposure, Assessed on Patient-reported Questionnaire [ Time Frame: Every 4 weeks through Week 52 ] [ Designated as safety issue: No ]
  • Food-allergic Reactions As Assessed by the Ewan Scale [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
  • Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peanut Hypersensitivity
Drug: omalizumab
SC repeating dose
Experimental: 1
Intervention: Drug: omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
Not Provided
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
Both
6 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00382148
Q3623g
Not Provided
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