Rh Disease Clinical Trial
Official title:
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03719469 -
Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis
|