{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["27(6)"],"submitter":["Escobar M"],"pubmed_abstract":["Introduction
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.Aim
To assess EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care.Methods
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 μ"],"journal":["Haemophilia : the official journal of the World Federation of Hemophilia"],"pagination":["921-931"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9292935"],"repository":["biostudies-literature"],"pubmed_title":["The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors."],"pmcid":["PMC9292935"],"pubmed_authors":["Macie C","Sidonio R","Wilkinson TA","Young G","Castaman G","Kessler C","Srivastava A","Shapiro AD","Boix SB","Wang M","Recht M","Al-Sabbagh A","Hermans C","Escobar M","Leissinger C","Mahlangu J","Quon D","Negrier C","Vilchevska KV","Miesbach W","Journeycake J","Callaghan M","de Moerloose P","Mitha IH","Alexander WA","Ducore J","Luck J","Bonzo D","Schved JF","Stasyshyn O"],"additional_accession":[]},"is_claimable":false,"name":"The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors.","description":"Introduction
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.Aim
To assess EB safety, immunogenicity and thrombotic potential in children and adults who received EB for treatment of bleeding and perioperative care.Methods
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 μ","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Nov","modification":"2026-05-09T19:59:59.208Z","creation":"2022-08-06T14:44:39.086Z"},"accession":"S-EPMC9292935","cross_references":{"pubmed":["34636112"],"doi":["10.1111/hae.14419"]}}