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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.
ClinicalTrials.gov Identifier: NCT00382148
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : December 15, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Peanut Hypersensitivity Drug: omalizumab Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIb, Open-Label Study of Xolair (Omalizumab) in Peanut-Allergic Subjects Randomized to Study Drug in Study Q2788g (TOPS)
Study Start Date : November 2006
Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Omalizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: omalizumab
SC repeating dose


Outcome Measures

Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: Through Week 52 ]

Secondary Outcome Measures :
  1. Food Allergen Exposure, Assessed on Patient-reported Questionnaire [ Time Frame: Every 4 weeks through Week 52 ]
  2. Food-allergic Reactions As Assessed by the Ewan Scale [ Time Frame: Through Week 52 ]
  3. Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs [ Time Frame: Through Week 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382148


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Dennis Wong, M.D. Genentech, Inc.
More Information

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00382148     History of Changes
Other Study ID Numbers: Q3623g
First Posted: September 28, 2006    Key Record Dates
Results First Posted: December 15, 2009
Last Update Posted: December 15, 2009
Last Verified: November 2009

Keywords provided by Genentech, Inc.:
TOPS
Peanut allergy
Peanut-induced allergy
Allergy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents