Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers

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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00952575

Enrollment

Registered

2009-08-06

Start date

2009-08-31

Completion date

2011-07-31

Last updated

2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Prevention of foeto-maternal allo-immunisation

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.

Interventions

DRUGpolyclonal anti-D immunoglobulin

single injection of 300 µg

DRUGmonoclonal anti-D immunoglobulin

Comparison of different dosages of LFB-R593

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy RhD-negative volunteers * Males and definitively sterile females * No prior sensitization to RhD antigen

Exclusion criteria

* Healthy RhD-positive volunteers

Design outcomes

Primary

Measure	Time frame
Clearance of RhD-positive red blood cells	within 2 weeks after RBC injection

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026