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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
Information obtained from ClinicalTrials.gov on October 04, 2010
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: Recruiting

Sponsored by: Laboratoire franšais de Fractionnement et de Biotechnologies

Official(s) and/or principal investigator(s):
Thomas Kornicke, Principal Investigator, Affiliation: Parexel

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.

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, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Clearance of RhD-positive red blood cells

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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; Recruiting
Thomas KOERNICKE, Phone: +49 30 30685 9676, Email: thomas.koernicke@parexel.com
Thomas KOERNICKE, Principal Investigator
Additional Information

Starting date: August 2009
Last updated: July 23, 2010

Page last updated: October 04, 2010

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