Status:
COMPLETED
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
Lead Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Collaborating Sponsors:
Parexel
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Healthy RhD-negative volunteers
- Males and definitively sterile females
- No prior sensitization to RhD antigen
Exclusion
- Healthy RhD-positive volunteers
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00952575
Start Date
August 1 2009
End Date
July 1 2011
Last Update
September 13 2011
Active Locations (1)
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1
Parexel Early Phase Clinical Unit
Berlin, Germany, 14050