NCT00952575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2 healthy

Timeline
Completed

Started Aug 2009

Typical duration for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

1.9 years

First QC Date

August 3, 2009

Last Update Submit

September 12, 2011

Conditions

Healthy

Keywords

Prevention of foeto-maternal allo-immunisation

Outcome Measures

Primary Outcomes (1)

  • Clearance of RhD-positive red blood cells

    within 2 weeks after RBC injection

Study Arms (2)

polyclonal anti-D immunoglobulin

ACTIVE COMPARATOR
Drug: polyclonal anti-D immunoglobulin

Monoclonal anti-D immunoglobulin

EXPERIMENTAL
Drug: monoclonal anti-D immunoglobulin

Interventions

polyclonal anti-D immunoglobulinDRUG

single injection of 300 µg

polyclonal anti-D immunoglobulin
monoclonal anti-D immunoglobulinDRUG

Comparison of different dosages of LFB-R593

Monoclonal anti-D immunoglobulin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Healthy RhD-positive volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel Early Phase Clinical Unit

Berlin, 14050, Germany

Location

Study Officials

  • Thomas Kornicke

    Parexel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

DE(1)