{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["8(3)"],"submitter":["Zulfikar B"],"funding":["Baxalta US Inc. and Baxalta Innovations GmbH"],"pubmed_abstract":["<b>Background</b>  Activated prothrombin complex concentrate (aPCC) is indicated for bleed treatment and prevention in patients with hemophilia with inhibitors. The safety and tolerability of intravenous aPCC at a reduced volume and faster infusion rates were evaluated. <b>Methods</b>  This multicenter, open-label trial (NCT02764489) enrolled adults with hemophilia A with inhibitors. In part 1, patients were randomized to receive three infusions of aPCC (85 ± 15 U/kg) at 2 U/kg/min (the approved standard rate at the time of the study), in a regular or 50% reduced volume, and were then crossed over to receive three infusions in the alternative volume. In part 2, patients received three sequential infusions of aPCC in a 50% reduced volume at 4 U/kg/min and then at 10 U/kg/min. Primary outcom"],"journal":["TH open : companion journal to thrombosis and haemostasis"],"pagination":["e273-e282"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11230701"],"repository":["biostudies-literature"],"pubmed_title":["Reduced Volume and Faster Infusion Rate of Activated Prothrombin Complex Concentrate: A Phase 3b/4 Trial in Adults with Hemophilia A with Inhibitors."],"pmcid":["PMC11230701"],"pubmed_authors":["Nekkal SM","Gazda HT","Ettingshausen CE","Lelli A","Mahlangu J","Ploder B","Zulfikar B","Uaprasert N","Windyga J","Ross C"],"additional_accession":[]},"is_claimable":false,"name":"Reduced Volume and Faster Infusion Rate of Activated Prothrombin Complex Concentrate: A Phase 3b/4 Trial in Adults with Hemophilia A with Inhibitors.","description":"<b>Background</b>  Activated prothrombin complex concentrate (aPCC) is indicated for bleed treatment and prevention in patients with hemophilia with inhibitors. The safety and tolerability of intravenous aPCC at a reduced volume and faster infusion rates were evaluated. <b>Methods</b>  This multicenter, open-label trial (NCT02764489) enrolled adults with hemophilia A with inhibitors. In part 1, patients were randomized to receive three infusions of aPCC (85 ± 15 U/kg) at 2 U/kg/min (the approved standard rate at the time of the study), in a regular or 50% reduced volume, and were then crossed over to receive three infusions in the alternative volume. In part 2, patients received three sequential infusions of aPCC in a 50% reduced volume at 4 U/kg/min and then at 10 U/kg/min. Primary outcom","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Jul","modification":"2026-07-15T05:11:38.515Z","creation":"2025-07-24T03:05:47.167Z"},"accession":"S-EPMC11230701","cross_references":{"pubmed":["38983688"],"doi":["10.1055/s-0044-1787781"]}}