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

NCT ID: NCT00382148

Last Updated: 2009-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

Brief Summary

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.

Conditions

Peanut Hypersensitivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

SC repeating dose

Interventions

omalizumab

SC repeating dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Genentech, Inc.

Principal Investigators

Dennis Wong, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

Q3623g

Identifier Type: -

Identifier Source: org_study_id