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NCT00198289 · ClinicalTrials.gov registry record · Phase 2
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00198289 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 30 participants.
The verdict
NCT00198289, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus. The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
Interventions
- DRUG Aurexis® (tefibazumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00198289
The ClinicalTrials.gov registry entry for NCT00198289 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aurexis® (tefibazumab) is the first listed.
NCT00198289 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00198289 about?
NCT00198289 is a clinical study titled "Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs". Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is d...
What is the current status of trial NCT00198289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-04. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00198289?
The interventions under investigation include: Aurexis® (tefibazumab) (DRUG).
Who is sponsoring clinical trial NCT00198289?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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