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EP594 : SAFETY OF RAVULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: STUDY 301/302 2-YEAR RESULTS

Researchers

Presenter

  • Austin Kulasekararaj

Principal Investigators

  • Morag Griffin

  • Saskia Langemeijer

  • Kensuke Usuki

  • Alexander Kulagin

  • Masayo Ogawa

  • Ji Yu

  • Arshad Mujeebuddin

  • Jun-ichi Nishimura

  • Jong Wook Lee

  • Rgis Peffault de Latour

Medical Centers

  • Osaka University Graduate School of Medicine, Suita, Japan

  • Department of Haematological Medicine, King’s College Hospital, National Institute for Health Research and Wellcome King’s Clinical Research Facility and King’s College London,London,United Kingdom

  • NHS Teaching Hospitals Leeds,Leeds,United Kingdom

  • Department of Laboratory Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of

  • Hospital Saint Antoine, Paris, France

  • Radboudumc, Nijmegen, Netherlands

  • NTT Medical Center Tokyo, Tokyo, Japan

  • RM Gorbacheva Research Institute, Pavlov University,St Petersburg,Russia

  • Alexion Pharmaceuticals, Inc., Boston, United States

Locations

  • Japan

  • United Kingdom

  • Republic of South Korea

  • France

  • Netherlands

  • Russia

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Blood/haematological Diseases

Disease

  • Paroxysmal nocturnal hemoglobinuria

Biomarkers

  • Lactate dehydrogenase

Drug/Treatment

  • Eculizumab

Outcome

  • N/A


Study Design

  • Randomized

  • Open Label

  • Non Inferiority

  • Multicenteric

Phase

  • III

Study Id's

  • NCT02946463

  • NCT03056040

Sponsors

  • N/A

Result

  • N/A