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

NCT ID: NCT00952575

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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polyclonal anti-D immunoglobulin

Group Type ACTIVE_COMPARATOR

polyclonal anti-D immunoglobulin

Intervention Type DRUG

single injection of 300 µg

Monoclonal anti-D immunoglobulin

Group Type EXPERIMENTAL

monoclonal anti-D immunoglobulin

Intervention Type DRUG

Comparison of different dosages of LFB-R593

Interventions

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polyclonal anti-D immunoglobulin

single injection of 300 µg

Intervention Type DRUG

monoclonal anti-D immunoglobulin

Comparison of different dosages of LFB-R593

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Healthy RhD-positive volunteers
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kornicke

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

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Parexel Early Phase Clinical Unit

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ADNC-0726

Identifier Type: -

Identifier Source: org_study_id

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