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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952575
First Posted: August 6, 2009
Last Update Posted: September 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parexel
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
  Purpose
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.

Condition Intervention Phase
Healthy Drug: polyclonal anti-D immunoglobulin Drug: monoclonal anti-D immunoglobulin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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

Resource links provided by NLM:


Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

Primary Outcome Measures:
  • Clearance of RhD-positive red blood cells [ Time Frame: within 2 weeks after RBC injection ]

Enrollment: 78
Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: polyclonal anti-D immunoglobulin Drug: polyclonal anti-D immunoglobulin
single injection of 300 µg
Experimental: Monoclonal anti-D immunoglobulin Drug: monoclonal anti-D immunoglobulin
Comparison of different dosages of LFB-R593

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy RhD-positive volunteers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952575


Locations
Germany
Parexel Early Phase Clinical Unit
Berlin, Germany, 14050
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Parexel
Investigators
Principal Investigator: Thomas Kornicke Parexel
  More Information

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT00952575     History of Changes
Other Study ID Numbers: ADNC-0726
First Submitted: August 3, 2009
First Posted: August 6, 2009
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Prevention of foeto-maternal allo-immunisation

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Rho(D) Immune Globulin
gamma-Globulins
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs