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LB 01.1 : A Phase 3 study (ATLAS-PPX) to evaluate efficacy and safety of fitusiran, an siRNA therapeutic, in people with haemophilia A or B who have switched from prior factor or bypassing agent prophylaxis

Researchers

Presenter

  • G. Kenet

Principal Investigators

  • B. Zulfikar

  • B. Antmen

  • P. Kampmann

  • T. Matsushita

  • C. You

  • K. Vilchevska

  • C. Bagot

  • A. Sharif

  • F. Peyvandi

  • G. Young

  • C. Negrier

  • T. Quan

  • S. Poloskey

  • C. Sussebach

  • S. Andersson

  • B. Mei

  • K. Kavakli

Medical Centers

  • Sheba medical center& Tel Aviv University, Tel Aviv, Tel Aviv, Israel

  • Children's Health Ireland at Crumlin Dublin 2 Ireland

  • Istanbul University Onkology Institute, Istanbul, Turkey

  • Department of Pediatric Hematology/Oncology and Bone Marrow Transplantation Unit, Faculty of Medicine, Acibadem University, Adana Hospital, Adana, Adana, Turkey

  • Department of Hematology, University Hospital Rigshospitalet, Copenhagen, Denmark

  • Department of Transfusion Medicine, Nagoya University Hospital, Nagoya, Japan

  • Department of Pediatrics, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, South Korea, Daejeon, Ch'ungch'ong-namdo, Republic of Korea

  • National Childrens Specialized Hospital Okhmatdet, Kiev, Ukraine

  • Department of Pathology, Glasgow Royal Infirmary, Glasgow, United Kingdom

  • Hospital Sultanah Aminah, Johor Bahru, Johor, Malaysia

  • Fondazione IRCCS Ca’ Granda - Ospedale Maggiore Policlinico, UOC Medicina Generale, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, and Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Lombardia, Italy

  • Hemostasis and Thrombosis Center, Cancer and Blood Diseases Institute, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California, United States

  • Louis Pradel University Hospital, Claude Bernard University Lyon 1, Lyon, Auvergne, France

  • Sanofi, Chengdu, Sichuan, China (People's Republic)

  • STC Biologics, Cambridge, Massachusetts, United States

  • Sanofi, Frankfurt, Hessen, Germany

  • Imagia, Montreal, Quebec, Canada

  • Sanofi, Cambridge, MA, USA, Cambridge, Massachusetts, United States

  • Department of Hematology, Ege University Faculty of Medicine, Children's Hospital, Izmir, Turkey, Izmir, Izmir, Turkey

Locations

  • Israel

  • Ireland

  • Turkey

  • Denmark

  • Japan

  • Republic of South Korea

  • Ukraine

  • United Kingdom

  • Malaysia

  • Italy

  • United States

  • France

  • China

  • Germany

  • Canada

Companies

  • N/A

Study Components

Therapeutic Area

  • Blood/haematological Diseases

Disease

  • Hemophilia

Biomarkers

  • N/A

Drug/Treatment

  • N/A

Outcome

  • N/A

Study Design

  • Open Label

  • Multinational

Phase

  • III

Study Id's

  • NCT03549871

Sponsors

  • N/A

Result

  • N/A

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