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

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ClinicalTrials.gov Identifier: NCT00952575
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : September 13, 2011
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: polyclonal anti-D immunoglobulin Drug: monoclonal anti-D immunoglobulin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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

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

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT00952575     History of Changes
Other Study ID Numbers: ADNC-0726
First Posted: August 6, 2009    Key Record Dates
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