{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["28(4)"],"submitter":["Pipe SW"],"funding":["LFB SA"],"pubmed_abstract":["<h4>Introduction</h4>Eptacog beta is a new recombinant activated human factor VII bypassing agent approved in the United States for the treatment and control of bleeding in patients with haemophilia A or B with inhibitors 12 years of age or older.<h4>Aim</h4>To prospectively assess in a phase 3 clinical trial (PERSEPT 2) eptacog beta efficacy and safety for treatment of bleeding in children <12 years of age with haemophilia A or B with inhibitors.<h4>Methods</h4>Using a randomised crossover design, subjects received initial doses of 75 or 225 μg/kg eptacog beta followed by 75 μg/kg dosing at predefined intervals (as determined by clinical response) to treat bleeding episodes (BEs). Treatment success criteria included a haemostasis evaluation of 'excellent' or 'good' without use of addition"],"journal":["Haemophilia : the official journal of the World Federation of Hemophilia"],"pagination":["548-556"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9542908"],"repository":["biostudies-literature"],"pubmed_title":["Eptacog beta efficacy and safety in the treatment and control of bleeding in paediatric subjects (<12 years) with haemophilia A or B with inhibitors."],"pmcid":["PMC9542908"],"pubmed_authors":["Macie C","Meeks SL","Wilkinson TA","Young G","Castaman G","Pipe SW","Nowak-Gottl U","Shapiro AD","Martinez LV","Wang M","Recht M","Hermans C","Escobar M","Mahlangu J","Windyga J","Carcao M","Sauty E","Negrier C","Chrisentery-Singleton T","Vilchevska KV","Mitchell IS","Chitlur M","Journeycake J","Mitha IH","Alexander WA","Davis JA","Ducore J","Dunn AL","Bonzo D","Khan O","Stasyshyn O"],"additional_accession":[]},"is_claimable":false,"name":"Eptacog beta efficacy and safety in the treatment and control of bleeding in paediatric subjects (<12 years) with haemophilia A or B with inhibitors.","description":"<h4>Introduction</h4>Eptacog beta is a new recombinant activated human factor VII bypassing agent approved in the United States for the treatment and control of bleeding in patients with haemophilia A or B with inhibitors 12 years of age or older.<h4>Aim</h4>To prospectively assess in a phase 3 clinical trial (PERSEPT 2) eptacog beta efficacy and safety for treatment of bleeding in children <12 years of age with haemophilia A or B with inhibitors.<h4>Methods</h4>Using a randomised crossover design, subjects received initial doses of 75 or 225 μg/kg eptacog beta followed by 75 μg/kg dosing at predefined intervals (as determined by clinical response) to treat bleeding episodes (BEs). Treatment success criteria included a haemostasis evaluation of 'excellent' or 'good' without use of addition","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jul","modification":"2026-05-31T16:08:11.946Z","creation":"2025-02-19T01:28:29.656Z"},"accession":"S-EPMC9542908","cross_references":{"pubmed":["35475308"],"doi":["10.1111/hae.14563"]}}