Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
Information source: Laboratoire franšais de Fractionnement et de Biotechnologies
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: polyclonal anti-D immunoglobulin (Drug); monoclonal anti-D immunoglobulin (Drug)
Phase: Phase 2
Sponsored by: Laboratoire franšais de Fractionnement et de Biotechnologies
Official(s) and/or principal investigator(s):
Thomas Kornicke, Principal Investigator, Affiliation: Parexel
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.
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Clearance of RhD-positive red blood cells
Minimum age: 18 Years.
Maximum age: 60 Years.
- Healthy RhD-negative volunteers
- Males and definitively sterile females
- No prior sensitization to RhD antigen
- Healthy RhD-positive volunteers
Locations and Contacts
Parexel Early Phase Clinical Unit, Berlin 14050, Germany
Starting date: August 2009
Last updated: September 12, 2011