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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014