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

Tracking Information

First Received Date ^ICMJE

August 3, 2009

Last Updated Date

September 12, 2011

Start Date ^ICMJE

August 2009

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clearance of RhD-positive red blood cells [ Time Frame: within 2 weeks after RBC injection ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00952575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: polyclonal anti-D immunoglobulin
single injection of 300 µg
Drug: monoclonal anti-D immunoglobulin
Comparison of different dosages of LFB-R593

Study Arm (s)

Active Comparator: polyclonal anti-D immunoglobulin
Intervention: Drug: polyclonal anti-D immunoglobulin
Experimental: Monoclonal anti-D immunoglobulin
Intervention: Drug: monoclonal anti-D immunoglobulin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Healthy RhD-positive volunteers

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00952575

Other Study ID Numbers ^ICMJE

ADNC-0726

Has Data Monitoring Committee

Yes

Responsible Party

Laboratoire français de Fractionnement et de Biotechnologies

Study Sponsor ^ICMJE

Laboratoire français de Fractionnement et de Biotechnologies

Collaborators ^ICMJE

Parexel

Investigators ^ICMJE

Principal Investigator:

Thomas Kornicke

Parexel

Information Provided By

Laboratoire français de Fractionnement et de Biotechnologies

Verification Date

September 2011

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

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