Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449651
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-04
Brief Title:
A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia FNAIT
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia FNAIT in At-risk Pregnancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
FREESIA-1
Brief Summary:
The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of fetal and neonatal alloimmune thrombocytopenia FNAIT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2023-504307-88 | EUDRACT_NUMBER | None | None |
| 2023-504307-88-00 | REGISTRY | None | None |
| 80202135FNAIT3001 | OTHER | Janssen Research Development LLC | None |