Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198289
Status:
COMPLETED
Last Update Posted:
2013-03-29
First Post:
2005-09-09
Brief Title:
Aurexis in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None