Status:
COMPLETED
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Lead Sponsor:
Genentech, Inc.
Conditions:
Peanut Hypersensitivity
Eligibility:
All Genders
6-75 years
Phase:
PHASE2
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 Stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00382148
Start Date
November 1 2006
Last Update
December 15 2009
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