Stopped: This study was terminated early by the sponsor due to insufficient drug exposure to achieve the intended therapeutic effect.
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
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Number of Participants With Treatment Related Adverse Events as Defined by CTCAE 5.0
Timeframe: Approx. Gestational Week (GW) <16, 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38; at birth (~40), Post Partum (PP) Week 4, 10 week
Maternal Exposure to RLYB212 as Measured in Serum
Timeframe: Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4