Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00952575
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2009-08-03
Brief Title:
Dose-finding Study of LFB-R593 A Monoclonal Anti-RhD Antibody in Healthy RhD Negative Volunteers
Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Organization:
Laboratoire français de Fractionnement et de Biotechnologies
Study Overview
Official Title:
A Phase II Open-label Randomised Dose-finding Study to Compare the Efficacy in Terms of Clearance of RhD-positive RBCs and Safety of LFB-R593 a Monoclonal Anti-RhD Antibody vs a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual thereby preventing RhD-alloimmunisation
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