Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02287896
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2014-10-28
Brief Title:
Pharmacokinetics and Safety of Roledumab in RhD-negative Pregnant Women Carrying an RhD-positive Foetus
Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Organization:
Laboratoire français de Fractionnement et de Biotechnologies
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-000269-35 | EUDRACT_NUMBER | None | None |