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Clinical Trials/NCT00086606
NCT00086606TerminatedPhase 2

A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Oral Food Challenge Trial of Xolair (Omalizumab) in Peanut Allergy

Genentech, Inc.1 site in 1 country150 target enrollmentStarted: June 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
150
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
6 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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