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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:
Collaborator:
Parexel
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:
NCT00952575
First received: August 3, 2009
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT00952575     History of Changes
Other Study ID Numbers: ADNC-0726
Study First Received: August 3, 2009
Last Updated: September 12, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on May 19, 2013