64th ASH Annual Meeting and Exposition: 322. Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological: Looking Forward: Novel Therapies and Diagnostic Modalities for Bleeding Disorders II

Symposia: Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological Oral and Poster Abstracts
Oral

Research, Bleeding and Clotting, bleeding disorders, Biological therapies, artificial intelligence (AI), Antibody Therapy, clinical trials, hemophilia, Bispecific Antibody Therapy, epidemiology, Clinical Research, drug development, Diseases, Therapies, real-world evidence, Adverse Events, Technology and Procedures, machine learning

288-290 (Ernest N. Morial Convention Center)

Moderators:

Suely M Rezende, MD, PhD, Universidade Federal de Minas Gerais and Maissaa Janbain,

Disclosures:

Janbain: Takeda: Consultancy, Speakers Bureau; BioMarin: Consultancy, Speakers Bureau; CSL Behring: Consultancy, Speakers Bureau; Sanofi: Consultancy, Speakers Bureau; Genentech: Consultancy, Research Funding; Octapharma: Consultancy; Bayer: Other: Steering Committee , Speakers Bureau; Sobi: Consultancy.

This session will focus on novel therapies and diagnostic modalities for Hemophilia A and B.

2:00 PM

187

Emicizumab Prophylaxis for the Treatment of Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Interim Analysis of the HAVEN 7 Study

Steven W. Pipe, MD¹, Peter Collins, MD²^*, Christophe Dhalluin, PhD³^*, Gili Kenet, MD^4,5, Christophe Schmitt, PharmD³^*, Muriel Buri, PhD³^*, Víctor Jiménez-Yuste, MD, PhD⁶^*, Flora Peyvandi, MD^7,8, Guy Young, MD⁹, Johannes Oldenburg, MD¹⁰^*, Maria Elisa Mancuso, MD¹¹^*, Anna Kiialainen, PhD³^*, Tiffany Chang, MD, MAS¹²^*, Michaela Lehle, PhD³ and Karin Fijnvandraat, MD¹³^*

¹University of Michigan, Ann Arbor, MI
²School of Medicine, Cardiff University, Cardiff, United Kingdom
³F. Hoffmann-La Roche Ltd, Basel, Switzerland
⁴Sheba Medical Center, Ramat Gan, Israel
⁵Tel Aviv University, Tel Aviv, Israel
⁶La Paz University Hospital, Autónoma University, Madrid, Spain
⁷Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia, Milan, Italy
⁸Thrombosis Center and Università degli Studi di Milano, Milan, Italy
⁹Children’s Hospital Los Angeles, Los Angeles, CA
¹⁰University of Bonn, Bonn, Germany
¹¹IRCCS Humanitas Research Hospital, Rozzano, Italy
¹²Spark Therapeutics, Inc., San Francisco, CA
¹³University of Amsterdam, Amsterdam, Netherlands

2:15 PM

188

Serpinpc in Persons with Severe Hemophilia (PwH): Updated Results from a Multi-Center, Multi-Part, First-in-Human Study

Trevor Baglin¹^*, Annelize Koch²^*, Irina Mocanu³^*, Levani Makhaldiani⁴^* and James A. Huntington, PhD¹

¹ApcinteX Ltd (a Centessa Pharmaceuticals company), Altrincham, United Kingdom
²Simbec-Orion Clinical Pharmacology, Merthyr Tydfil, United Kingdom
³Arensia Exploratory Medicine, Chisinau, Moldova, The Republic of
⁴Arensia Exploratory Medicine, Tbilisi, Georgia

2:30 PM

189

Hemorrhagic and Thrombotic Adverse Events Associated with Emicizumab and Extended Half-Life FVIII Replacement Drugs in Patients with Hemophilia a: Data from the Eudravigilance Database

Maria Abbattista¹^*, Alessandro Ciavarella, MD^2,3^*, Declan Noone, MSc⁴^* and Flora Peyvandi, MD^5,6

¹IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico, Milano, It, ITA
²Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
³Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Milan, AL, Italy
⁴European Haemophilia Consortium, Brussels, Belgium
⁵Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy
⁶1. Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Milan, Italy

2:45 PM

190

A Computer-Aided Diagnosis Tool for the Detection of Hemarthrosis By Remote Joint Ultrasound in Patients with Hemophilia

Roberta Gualtierotti^1,2^*, Sara Arcudi, MD^1,2^*, Alessandro Ciavarella, MD^1,2^*, Marco Colussi, marco.colussi@unimi.it³^*, Sergio Mascetti, sergio.mascetti@unimi.it³^*, Claudio Bettini, claudio.bettini@unimi.it³^* and Flora Peyvandi, MD^1,2

¹Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy
²Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
³Department of Computer Science, Università degli Studi di Milano, Milan, Italy

3:00 PM

191

Subcutaneous Concizumab Prophylaxis in Patients with Hemophilia A or B with Inhibitors: Efficacy and Safety Results By Hemophilia Subtype from the Phase 3 Explorer7 Trial

Melissa Frei-Jones, MD, MS¹, Katarina Cepo, MD²^*, Roseline d'Oiron³^*, Ai Sim Goh⁴^*, Mary Mathias⁵^* and Jan Odgaard-Jensen⁶^*

¹Pediatric Hematology-Oncology, Joe R. and Teresa Lozano Long School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX
²Biopharm Medical & Science, Novo Nordisk A/S, Søborg, Denmark
³Reference Centre for Hemophilia and Congenital Rare Bleeding Disorders, Bicêtre Hospital AP-HP, University Paris-Saclay and UMR_S1176 INSERM, Le Kremlin-Bicêtre, France
⁴Hematology Unit, Hospital Pulau Pinang, Ministry of Health Malaysia, Penang, Malaysia
⁵Great Ormond Street Hospital For Children NHS Foundation Trust, London, GBR
⁶Novo Nordisk A/S, Søborg, Denmark

3:15 PM

192

Real-World Safety of Emicizumab: Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database

Francis Nissen, MD, PhD¹^*, Yanrong Jiang, MBBS, MRCP¹^*, Hwai Jing Hiew, MD, FRCPath¹^*, Martynas Aizenas, BSc¹^*, Guillermo Tobaruela, PharmD¹^* and Lyle Jew, PharmD²^*

¹F. Hoffmann-La Roche Ltd., Basel, Switzerland
²Genentech, Inc., South San Francisco

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^*signifies non-member of ASH

322.O1.6 322. Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological: Looking Forward: Novel Therapies and Diagnostic Modalities for Bleeding Disorders II