PERSEPT 3: A phase 3 clinical trial to evaluate the haemostatic efficacy of eptacog beta (recombinant human FVIIa) in perioperative care in subjects with haemophilia A or B with inhibitors

Surgical procedures in persons with haemophilia A or B with inhibitors (PwHABI) require the use of bypassing agents (BPA) and carry a high risk of complications. Historically, only two BPAs have been available; these are reported to have variable responses.

[1]  A. al‐Sabbagh,et al.  The safety of activated eptacog beta in the management of bleeding episodes and perioperative haemostasis in adult and paediatric haemophilia patients with inhibitors , 2021, Haemophilia : the official journal of the World Federation of Hemophilia.

[2]  J. Grandoni,et al.  Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human fviia) and emicizumab in congenital haemophilia A plasma , 2021, Haemophilia : the official journal of the World Federation of Hemophilia.

[3]  Michael Wang,et al.  2021 clinical trials update: Innovations in hemophilia therapy , 2020, American journal of hematology.

[4]  E. Santagostino,et al.  WFH Guidelines for the Management of Hemophilia, 3rd edition , 2020, Haemophilia : the official journal of the World Federation of Hemophilia.

[5]  C. Königs,et al.  Inhibitor incidence in an unselected cohort of previously untreated patients with severe hemophilia B: a PedNet study , 2020, Haematologica.

[6]  C. Leissinger,et al.  The evolution of factor VIIa in the treatment of bleeding in haemophilia with inhibitors , 2019, Haemophilia : the official journal of the World Federation of Hemophilia.

[7]  N. Goddard,et al.  Over two decades of orthopaedic surgery in patients with inhibitors—Quantifying the complication of bleeding , 2018, Haemophilia : the official journal of the World Federation of Hemophilia.

[8]  D. Cooper,et al.  Continuous infusion of recombinant activated factor VII: a review of data in congenital hemophilia with inhibitors and congenital factor VII deficiency , 2018, Journal of blood medicine.

[9]  A. Shapiro,et al.  The future of bypassing agents for hemophilia with inhibitors in the era of novel agents , 2018, Journal of thrombosis and haemostasis : JTH.

[10]  V. Jiménez‐Yuste,et al.  Recommendations on multidisciplinary management of elective surgery in people with haemophilia , 2018, Haemophilia : the official journal of the World Federation of Hemophilia.

[11]  M. Wang,et al.  Safety and dose‐dependency of eptacog beta (activated) in a dose escalation study of non‐bleeding congenital haemophilia A or B patients, with or without inhibitors , 2017, Haemophilia : the official journal of the World Federation of Hemophilia.

[12]  M. Wang,et al.  PERSEPT 1: a phase 3 trial of activated eptacog beta for on‐demand treatment of haemophilia inhibitor‐related bleeding , 2017, Haemophilia.

[13]  G. Castaman.  The role of recombinant activated factor VII in the haematological management of elective orthopaedic surgery in haemophilia A patients with inhibitors. , 2017, Blood transfusion = Trasfusione del sangue.

[14]  2017 Clinical trials update: Innovations in hemophilia therapy , 2017, American journal of hematology.

[15]  H. Ju,et al.  The efficacy of bypassing agents in surgery of hemophilia patients with inhibitors , 2015, Blood research.

[16]  C. Miller,et al.  Impact of inhibitors on hemophilia a mortality in the United States , 2015, American journal of hematology.

[17]  P. Jenkins,et al.  Total knee replacement in patients with haemophilia: the Scottish experience , 2013, Scottish medical journal.

[18]  L. Valentino,et al.  Multidisciplinary management of patients with haemophilia with inhibitors undergoing surgery in the United States: perspectives and best practices derived from experienced treatment centres , 2012, Haemophilia : the official journal of the World Federation of Hemophilia.

[19]  A. Pickard,et al.  Effect of acute bleeding on daily quality of life assessments in patients with congenital hemophilia with inhibitors and their families: observations from the dosing observational study in hemophilia. , 2012, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[20]  D. Cooper,et al.  U.S. survey of surgical capabilities and experience with surgical procedures in patients with congenital haemophilia with inhibitors , 2012, Haemophilia : the official journal of the World Federation of Hemophilia.

[21]  L. Valentino,et al.  Surgical Experience with rFVIIa (NovoSeven) in congenital haemophilia A and B patients with inhibitors to factors VIII or IX , 2011, Haemophilia : the official journal of the World Federation of Hemophilia.

[22]  N. Goddard,et al.  Consensus protocol for the use of recombinant activated factor VII [eptacog alfa (activated); NovoSeven®] in elective orthopaedic surgery in haemophilic patients with inhibitors , 2009, Haemophilia : the official journal of the World Federation of Hemophilia.

[23]  M. Carcao,et al.  Orthopaedic surgery in haemophilia patients with inhibitors: a practical guide to haemostatic, surgical and rehabilitative care , 2009, Haemophilia : the official journal of the World Federation of Hemophilia.

[24]  N. Stieltjes,et al.  Management of haemophilic arthropathy , 2008, Haemophilia : the official journal of the World Federation of Hemophilia.

[25]  L. Valentino,et al.  Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery , 2007, Thrombosis and Haemostasis.

[26]  J. Astermark,et al.  A randomized comparison of bypassing agents in hemophilia complicated by an inhibitor: the FEIBA NovoSeven Comparative (FENOC) Study. , 2007, Blood.

[27]  M. Poon,et al.  Therapeutic choices for patients with hemophilia and high‐titer inhibitors , 2001, American journal of hematology.

[28]  A D Shapiro,et al.  Prospective, Randomised Trial of Two Doses of rFVIIa (NovoSeven) in Haemophilia Patients with Inhibitors Undergoing Surgery , 1998, Thrombosis and Haemostasis.