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NCT01125748 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
A Phase 4 study of Allergic Asthma, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 176
- Enrollment target
- 20
- Study locations
NCT01125748: Completed Phase 4 study of Allergic Asthma, sponsored by Genentech.
NCT01125748 is a Phase 4 study of Allergic Asthma that has completed, run by Genentech. The registered enrollment target is 176 participants, roughly in line with the 162-participant average among 4 other Allergic Asthma trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125748, a Phase 4 study of Allergic Asthma, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 176 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.
Primary Outcome
A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically signific
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Omalizumab
- DRUG Asthma therapies
Study Locations (20)
California
- - Bakersfield
- - Fresno
- - Fresno
- - Granada Hills
- - Los Angeles
- - Los Angeles
- - Napa
- - Redwood City
- - Sacramento
- - San Francisco
- - San Mateo
- - Studio City
- - Walnut Creek
Colorado
- - Centennial
- - Thornton
Florida
- - Bay Pines
- - Clearwater
Alabama
- - Huntsville
Arkansas
- - Little Rock
Connecticut
- - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2010-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 4 |
What the finished NCT01125748 record still lists
NCT01125748 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 162-participant average among 4 other Allergic Asthma trials with a reported enrollment target.
The record links to 1 condition, with Allergic Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01125748 names 20 study sites across 6 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01125748 about?
NCT01125748 is a clinical study titled "A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy". This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatme...
What is the current status of trial NCT01125748?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 176 participants. The study started on 2010-05. Estimated completion is 2013-08.
What conditions does trial NCT01125748 study?
This clinical trial studies the following conditions: Allergic Asthma.
What interventions are being tested in trial NCT01125748?
The interventions under investigation include: Placebo (DRUG), Omalizumab (DRUG), Asthma therapies (DRUG).
Who is sponsoring clinical trial NCT01125748?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01125748 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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