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

Genentech

Status and phase

Completed

Phase 2

Conditions

Peanut Hypersensitivity

Treatments

Drug: omalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00382148

Q3623g

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

6 to 75 years old

Volunteers

No Healthy Volunteers

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