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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

Status: Completed

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.

Clinical Details

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. Gender(s): Both.


Inclusion Criteria:

- Healthy RhD-negative volunteers

- Males and definitively sterile females

- No prior sensitization to RhD antigen

Exclusion Criteria:

- Healthy RhD-positive volunteers

Locations and Contacts

Parexel Early Phase Clinical Unit, Berlin 14050, Germany
Additional Information

Starting date: August 2009
Last updated: September 12, 2011

Page last updated: August 23, 2015

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