At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 62 enrolled
Drug / intervention
ROLEDUMABdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Laboratoire français de Fractionnement et de Biotechnologies·interventional·Posted Nov 11, 2014·Updated Jul 13, 2020
In Brief
A Phase 2 clinical trial evaluating ROLEDUMAB for Rh Disease. Completed, enrolled 62 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRh Disease
CountriesFrance
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedNov 2014
Primary CompletionSep 2017
TodayJul 2026
First PostedNov 11, 2014
Enrollment StartApr 1, 2014
Primary CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.6 years ago
Interventions
ROLEDUMABdrug
See Arm description