NCT00086606

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

First QC Date

July 6, 2004

Last Update Submit

January 17, 2013

Conditions

Allergy

Keywords

Peanut

Interventions

Xolair (omalizumab)DRUG

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trial Information Support Line

Denver, Colorado, 80012, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Yamo Deniz, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2004

First Posted

July 9, 2004

Study Start

June 1, 2004

Study Completion

April 1, 2006

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

US(1)