Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)
This study is currently recruiting participants.
Verified March 2013 by Genentech
Sponsor:
Genentech
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00813748
First received: December 22, 2008
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Asthma |
Drug: Xolair |
Phase 4 |
| Study Type: | Observational |
| Official Title: | Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing |
Resource links provided by NLM:
Further study details as provided by Genentech:
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
primary care clinic
Criteria
Inclusion Criteria for Cases:
- Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair
Inclusion Criteria for Controls:
- At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
- At least one dose of Xolair in the 18 months before the date of the case event (index date)
- No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813748
Contacts
| Contact: GDS SAE Hotline | 888-835-2555 |
Locations
| United States, California | |
| Investigational Site | Recruiting |
| Los Angeles, California, United States, 90025 | |
| United States, Florida | |
| Investigational Site | Recruiting |
| Valrico, Florida, United States, 33596 | |
| United States, Illinois | |
| Investigational Site | Recruiting |
| Hinsdale, Illinois, United States, 60521 | |
| United States, Missouri | |
| Investigational Site | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| Investigational Site | Recruiting |
| New York, New York, United States, 10022 | |
| United States, Pennsylvania | |
| Investigational Site | Recruiting |
| Blue Bell, Pennsylvania, United States, 19422 | |
| United States, Texas | |
| Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Genentech
Investigators
| Study Director: | Abdelkader Rahmaoui, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Genentech |
| ClinicalTrials.gov Identifier: | NCT00813748 History of Changes |
| Other Study ID Numbers: | Q4458g |
| Study First Received: | December 22, 2008 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
Asthma Anaphylaxis |
Additional relevant MeSH terms:
|
Anaphylaxis Asthma Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013