MedDataX Logo

A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g

NCT ID: NCT00382148

Last Updated: 2009-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peanut Hypersensitivity

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

TOPS Peanut allergy Peanut-induced allergy Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

omalizumab

Intervention Type DRUG

SC repeating dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

omalizumab

SC repeating dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Genentech, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dennis Wong, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Q3623g

Identifier Type: -

Identifier Source: org_study_id