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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
ClinicalTrials.gov Identifier:
NCT00382148
First received: September 26, 2006
Last updated: November 12, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Peanut Hypersensitivity
 Drug: omalizumab
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: Through Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: November 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: omalizumab
SC repeating dose

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382148

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

Additional Information:
Clinical Study Report Synopsis  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00382148     History of Changes
Other Study ID Numbers: Q3623g
Study First Received: September 26, 2006
Results First Received: November 5, 2009
Last Updated: November 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
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
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 22, 2013