An HPA-1a–positive platelet–depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo–controlled, single-center, phase 1/2 proof-of-concept study
Geisen C, Kjaer M, Fleck E, Skogen B, Armstrong R, Behrens F, Bhagwagar Z, Braeuninger S, Mortberg A, Olsen K, Gastón Schäfer S, Walter C, Seifried E, Wikman A, Kjeldsen-Kragh J, Koehm M. An HPA-1a–positive platelet–depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo–controlled, single-center, phase 1/2 proof-of-concept study. Journal Of Thrombosis And Haemostasis 2022, 21: 838-849. PMID: 36696185, DOI: 10.1016/j.jtha.2022.11.041.Peer-Reviewed Original ResearchMeSH KeywordsAntigens, Human PlateletFemaleFetusHumansImmunoglobulin GInfant, NewbornIntegrin beta3MalePregnancySingle-Blind MethodThrombocytopenia, Neonatal AlloimmuneConceptsFetal/Neonatal Alloimmune ThrombocytopeniaNeonatal alloimmune thrombocytopeniaHPA-1aAlloimmune thrombocytopeniaHuman platelet antigen 1aTreatment-emergent adverse eventsPlacebo 1 hourHPA-1a antibodiesFNAIT casesHyperimmune IgGPrimary endpointAdverse eventsFetus/Healthy menSingle doseAntigen 1aHLA-A2Concept studyCohort 1PlaceboFlow cytometryThrombocytopeniaPlateletsAdministrationWeeks