Trials / Completed
CompletedNCT02287896
Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus
Pharmacokinetics and Safety of Roledumab, a Fully Human Recombinant Monoclonal Anti-RhD Antibody, in RhD-negative Pregnant Woman Carrying an RhD-positive Foetus: a Phase IIb, Multicenter, Open-label Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in RhD-negative pregnant women carrying an RhD-positive foetus. To assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive fetus and newborns. In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in RhD-negative pregnant women carrying an RhD-positive fetus and the immunogenicity of Roledumab will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ROLEDUMAB | See Arm description |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2017-09-13
- Completion
- 2017-09-13
- First posted
- 2014-11-11
- Last updated
- 2020-07-13
- Results posted
- 2019-08-16
Locations
8 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02287896. Inclusion in this directory is not an endorsement.