Trials / Completed
CompletedNCT00952575
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | polyclonal anti-D immunoglobulin | single injection of 300 µg |
| DRUG | monoclonal anti-D immunoglobulin | Comparison of different dosages of LFB-R593 |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2009-08-06
- Last updated
- 2011-09-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00952575. Inclusion in this directory is not an endorsement.