Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00813748
First received: December 22, 2008
Last updated: March 7, 2014
Last verified: March 2014
  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:

Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 118
Study Start Date: March 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813748

Locations
United States, California
Investigational Site
Los Angeles, California, United States, 90025
United States, Florida
Investigational Site
Valrico, Florida, United States, 33596
United States, Illinois
Investigational Site
Hinsdale, Illinois, United States, 60521
United States, Missouri
Investigational Site
Kansas City, Missouri, United States, 64111
United States, New York
Investigational Site
New York, New York, United States, 10022
United States, Pennsylvania
Investigational Site
Blue Bell, Pennsylvania, United States, 19422
United States, Texas
Investigational Site
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 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Asthma
Anaphylaxis

Additional relevant MeSH terms:
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014