Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435845
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-21
Brief Title:
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
Sponsor:
Rallybio IPA LLC
Organization:
Rallybio IPA LLC
Study Overview
Official Title:
A Phase 2 Multicenter Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 purpose of this Phase 2 study is to assess the pharmacokinetics PK and safety of RLYB212 in HPA-1bb pregnant women at higher risk for HPA-1a alloimmunization and FNAIT
Detailed Description:
This study is a single-arm open-label multicenter study of RLYB212 in HPA-1bb pregnant participants at higher risk for the occurrence of HPA-1a alloimmunization and FNAIT A laboratory testing paradigm will be applied at screening to identify women at higher risk for HPA-1a alloimmunization Study IPA2202 is comprised of three phases a two-part screening phase an antenatal treatment phase and a postpartum follow-up phase Study duration for each participant is anticipated to be 44 weeks inclusive of the screening visits through the Week 10 postpartum visit
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-512651-20-00 | CTIS | None | None |