biostudies-literatureUnknown27(6)Escobar M<h4>Introduction</h4>Haemophilia patients with inhibitors often require a bypassing agent (BPA) for bleeding episode management. Eptacog beta (EB) is a new FDA-approved recombinant activated human factor VII BPA for the treatment and control of bleeding in haemophilia A or B patients with inhibitors (≥12 years of age). We describe here the EB safety profile from the three prospective Phase 3 clinical trials performed to date.<h4>Aim</h4>To assess EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care.<h4>Methods</h4>Using a randomized crossover design, 27 subjects in PERSEPT 1 (12-54 years) and 25 subjects in PERSEPT 2 (1-11 years) treated bleeding episodes with 75 or 225 μg/kg EB initially followed by 75 μHaemophilia : the official journal of the World Federation of Hemophilia921-931https://www.ebi.ac.uk/biostudies/studies/S-EPMC9292935biostudies-literatureThe safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors.PMC9292935Macie CSidonio RWilkinson TAYoung GCastaman GKessler CSrivastava AShapiro ADBoix SBWang MRecht MAl-Sabbagh AHermans CEscobar MLeissinger CMahlangu JQuon DNegrier CVilchevska KVMiesbach WJourneycake JCallaghan Mde Moerloose PMitha IHAlexander WADucore JLuck JBonzo DSchved JFStasyshyn OfalseThe safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors.<h4>Introduction</h4>Haemophilia patients with inhibitors often require a bypassing agent (BPA) for bleeding episode management. Eptacog beta (EB) is a new FDA-approved recombinant activated human factor VII BPA for the treatment and control of bleeding in haemophilia A or B patients with inhibitors (≥12 years of age). We describe here the EB safety profile from the three prospective Phase 3 clinical trials performed to date.<h4>Aim</h4>To assess EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care.<h4>Methods</h4>Using a randomized crossover design, 27 subjects in PERSEPT 1 (12-54 years) and 25 subjects in PERSEPT 2 (1-11 years) treated bleeding episodes with 75 or 225 μg/kg EB initially followed by 75 μ2021-01-01T00:00:00Z2021 Nov2026-05-09T19:59:59.208Z2022-08-06T14:44:39.086ZS-EPMC92929353463611210.1111/hae.14419