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OpenTrials
Completed

NCT Number: NCT00952575

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Parexel Early Phase Clinical Unit

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Healthy RhD-positive volunteers

Treatment and study plan

polyclonal anti-D immunoglobulin

Drug

single injection of 300 µg

monoclonal anti-D immunoglobulin

Drug

Comparison of different dosages of LFB-R593

Primary outcomes

  1. Clearance of RhD-positive red blood cells

    Time frame: within 2 weeks after RBC injection

Sponsors and collaborators

Lead sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Industry

Collaborators

  • Parexel

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 6, 2009
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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