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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: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT00198289 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 30 participants
Start Date 2005-04
Est. Completion 2006-06
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT00198289 record still lists

NCT00198289 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Aurexis® (tefibazumab) is the first listed.

NCT00198289 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00198289's enrollment target sits among peer trials

30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00198289, the US trial registry maintained by the National Library of Medicine. NCT00198289 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.