190
Participants
Start Date
September 30, 2020
Primary Completion Date
September 30, 2027
Study Completion Date
September 30, 2027
Crovalimab
"Dosing depends on body weight. Participants will be dosed as follows:~* 5 kg to \< 12 kg: 100 mg IV on Week 1 Day 1 (W1D1); 85 mg SC on Week 1 Day 2 (W1D2) and Q2W from Week 3 until end of study~* 12 kg to \< 20 kg: 200 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 170 mg SC, Q2W from Week 5 until end of study~* 20 kg to \< 30 kg: 300 mg IV on W1D1; 85 mg SC on W1D2, Weeks 2, 3 and 4; 340 mg SC, Q4W from Week 5 until end of study~* 30 kg to \< 40 kg: 400 mg IV on W1D1; 170 mg SC on W1D2, Weeks 2, 3 and 4; 510 mg SC, Q4W from Week 5 until end of study~* 40 kg to \< 100 kg: 1000 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 680 mg SC, Q4W from Week 5 until end of study~* 100 kg: 1500 mg IV on W1D1; 340 mg SC W1D2, Weeks 2, 3 and 4; 1020 mg SC, Q4W from Week 5 until end of study."
Eculizumab
Eculizumab will be administered at a dose of 900 mg Q2W, as per the dosing schedule described above.
National Taiwan Universtiy Hospital, Taipei
Changhua Christian Hospital, Chang-hua
Semmelweis Egyetem, Budapest
Cliniques Universitaires Saint-Luc, Brussels
CHU UCL Namur / site Godinne, Yvoir
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin
King Faisal Specialist Hospital & Research Center, Riyadh
North Estonia Medical Centre Foundation, Tallinn
Complejo Hospitalario Universitario de Santiago., Santiago de Compostela
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology, Gaziantep
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario Clinico San Carlos, Madrid
Carolinas Healthcare System, Charlotte
Hospital Regional Universitario de Malaga, Málaga
Hospital U. Central de Asturias, Asturias
Istanbul University Istanbul Medical Faculty; Neurology, Istanbul
Marmara University Pendik Training and Research Hospital, Hematology Department, Istanbul
Hospital Universitario de Gran Canaria, Las Palmas
Ege University Medical Faculty; Hematology, Izmir
Hospital Universitario de Salamanca, Salamanca
Nationwide Children's Hospital, Columbus
Ulsan University Hospital, Ulsan
Hospital Universitario de Toledo, Toledo
Azienda Ospedaliera Universitaria Careggi, Florence
Ondokuz Mayis Univ. Med. Fac., Samsun
Hopital Claude Huriez - CHU Lille, Lille
National University Hospital, Singapore
Chronos Pesquisa Clinica, Taguatinga
Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Instituto Joinvilense de Hematologia E Oncologia, Joinville
Hospital das Clínicas FMRP-USP, Ribeirão Preto
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia, Santo André
Hospital Sírio-Libanês, São Paulo
Hospital Paulistano, São Paulo
Beneficencia Portuguesa de Sao Paulo, São Paulo
CISSS Chaudière-Appalaches, Lévis
Ustav hematologie a krevni transfuze, Prague
ELBLANDKLINIKUM Riesa, Riesa
General Hospital of Athens LAIKO, Athens
Attikon University General Hospital, Athens
St James's Hospital, Dublin
Fujita Health University Hospital, Aichi
Kobe University Hospital, Hyōgo
Tokushukai Takasago Seibu Hospital, Hyōgo
Ishikawa Prefectural Central Hospital, Ishikawa
Tokai University Hospital, Kanagawa
Mie University Hospital, Mie
Japanese Red Cross Society Suwa Hospital, Nagano
Nagasaki University Hospital, Nagasaki
Sasebo City General Hospital, Nagasaki
National Hospital Organization Okayama Medical Center, Okayama
The University of Osaka Hospital, Osaka
Iwate Prefectural Isawa Hospital, Ōshū
NTT Medical Center Tokyo, Tokyo
Tokyo Medical University Hospital, Tokyo
Toyama Prefectual Central Hospital, Toyama
Amsterdam UMC, Locatie AMC, Amsterdam
Szpital Uniwersytecki nr2 im. dr J. Biziela, Bydgoszcz
Samodzielny Publiczny Szpital Kliniczny nr 1, Lublin
Pratia Poznan, Skórzewo
MTZ Clinical Research Powered by Pratia, Warsaw
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Samsung Medical Center, Seoul
ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Universitari Vall d'Hebron, Barcelona
Akademiska Sjukhuset, Uppsala
Hualien Tzu Chi Hospital, Hualien City
Hacettepe University Medical Faculty; Neurology, Ankara
Collaborators (1)
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY