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A Safety and Efficacy Study of Xolair in Peanut Allergy

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ClinicalTrials.gov Identifier: NCT00086606
Recruitment Status : Terminated
First Posted : July 9, 2004
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.

Condition or disease Intervention/treatment Phase
Allergy Drug: Xolair (omalizumab) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy
Study Start Date : June 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy





Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a diagnosis of acute peanut allergy
  • The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
  • The patient is six to 75 years of age
  • The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
  • The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
  • The patient is able to swallow capsules

Exclusion Criteria:

  • Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
  • Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
  • Have a history of allergy to wheat protein
  • Have previously been exposed to monoclonal antibody treatment

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): NCT00086606


Locations
United States, Colorado
Trial Information Support Line
Denver, Colorado, United States, 80012
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Yamo Deniz, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00086606     History of Changes
Other Study ID Numbers: Q2788g
First Posted: July 9, 2004    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Genentech, Inc.:
Peanut

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