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NCT00813748 · ClinicalTrials.gov registry record
Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing
A clinical trial of Allergic Asthma, sponsored by Genentech.
- Completed
- Registry status
- 118
- Enrollment target
- 7
- Study locations
NCT00813748: Completed study of Allergic Asthma, sponsored by Genentech.
NCT00813748 is a study of Allergic Asthma that has completed, run by Genentech. The registered enrollment target is 118 participants, below the 176-participant average among 4 other Allergic Asthma trials with a reported enrollment target (33% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00813748, a study of Allergic Asthma, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- 118 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Conditions Studied
Interventions
- DRUG Xolair
Study Locations (7)
California
- Investigational Site - Los Angeles
Florida
- Investigational Site - Valrico
Illinois
- Investigational Site - Hinsdale
Missouri
- Investigational Site - Kansas City
New York
- Investigational Site - New York
Pennsylvania
- Investigational Site - Blue Bell
Texas
- Investigational Site - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-01 |
What the finished NCT00813748 record still lists
NCT00813748 is an observational study that tracks outcomes without assigning an intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 176-participant average among 4 other Allergic Asthma trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Allergic Asthma appearing as the primary indexed condition, and to 1 intervention - of which Xolair is the first listed.
NCT00813748 lists 7 locations in 7 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT00813748 about?
NCT00813748 is a clinical study titled "Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing". 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 r...
What is the current status of trial NCT00813748?
This trial is currently completed. The enrollment target is 118 participants. The study started on 2009-03. Estimated completion is 2014-01.
What conditions does trial NCT00813748 study?
This clinical trial studies the following conditions: Allergic Asthma.
What interventions are being tested in trial NCT00813748?
The interventions under investigation include: Xolair (DRUG).
Who is sponsoring clinical trial NCT00813748?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00813748 being conducted?
This trial has 7 study locations across California, Florida, Illinois, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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