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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
August 3, 2009
August 6, 2009
September 13, 2011
August 2009
July 2011   (Final data collection date for primary outcome measure)
Clearance of RhD-positive red blood cells [ Time Frame: within 2 weeks after RBC injection ]
Same as current
Complete list of historical versions of study NCT00952575 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy
  • Drug: polyclonal anti-D immunoglobulin
    single injection of 300 µg
  • Drug: monoclonal anti-D immunoglobulin
    Comparison of different dosages of LFB-R593
  • Active Comparator: polyclonal anti-D immunoglobulin
    Intervention: Drug: polyclonal anti-D immunoglobulin
  • Experimental: Monoclonal anti-D immunoglobulin
    Intervention: Drug: monoclonal anti-D immunoglobulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Healthy RhD-positive volunteers
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00952575
ADNC-0726
Yes
Not Provided
Not Provided
Laboratoire français de Fractionnement et de Biotechnologies
Laboratoire français de Fractionnement et de Biotechnologies
Parexel
Principal Investigator: Thomas Kornicke Parexel
Laboratoire français de Fractionnement et de Biotechnologies
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP