Phase
Condition
Proteinuria
Anemia
Bone Marrow Disorder
Treatment
Eculizumab
Crovalimab
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body weight >= 40 kg at screening.
Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.
Lactate Dehydrogenase Levels =< 2x the upper limit of normal (ULN) at screening.
Willingness and ability to comply with all study visits and procedures.
Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
Vaccination against Neisseria meningitidis serotypes A, C, W, and Y < 3 years priorto initiation of study treatment; or, if not previously done, vaccinationadministered no later than one week after the first drug administration.
Women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraception during the treatment period and for 10.5 months after the final dose of crovalimab or for 3 months after the final doseof eculizumab (or longer if required by the local product label).
Exclusion
Exclusion Criteria:
History of allogeneic bone marrow transplantation.
History of myelodysplastic syndrome with Revised International Prognostic ScoringSystem (IPSS-R) prognostic risk categories of intermediate, high and very high.
Pregnant or breastfeeding, or intending to become pregnant during the study, within 10.5 months after the final dose of crovalimab, or 3 months after the final dose ofeculizumab (or longer if required by the local product label).
Participation in another interventional treatment study with an investigationalagent or use of any experimental therapy within 28 days of screening or within 5half-lives of that investigational product, whichever was greater: participantsenrolled in an eculizumab or ravulizumab interventional study are eligible providedthey fulfill eligibility (e.g., are willing and able to comply with the studyassessments) and stop their participation in current trial beforerandomisation/enrolment.
Positive for Active Hepatitis B and C infection (HBV/HCV).
Concurrent disease, treatment, procedure, or surgery or abnormality in clinicallaboratory tests that could interfere with the conduct of the study, may pose anyadditional risk for the participant, or would, in the opinion of the investigator,preclude the participant's safe participation in and completion of the study.
History of or ongoing cryoglobulinemia at screening.
Study Design
Connect with a study center
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaSite Not Available
Westmead Hospital; Pharmacy
Northmead, New South Wales 2145
AustraliaSite Not Available
Liverpool Hospital
Sydney, New South Wales 2080
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Royal Perth Hospital
Perth, Western Australia 6000
AustraliaSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc; Pharmacy
Bruxelles, 1200
BelgiumSite Not Available
AZ Delta Campus Westlaan
Roeselare, 8800
BelgiumSite Not Available
CHU UCL Namur / site Godinne
Yvoir, 5530
BelgiumSite Not Available
Hospital Universitario Walter Cantidio - UFC
Fortaleza, CE 60430-370
BrazilSite Not Available
Nucleo de Pesquisa Clinica do Hospital da Crianca
Brasilia, DF 70684-831
BrazilSite Not Available
Chronos Pesquisa Clinica
Taguatinga, Distrito Federal 72145-450
BrazilSite Not Available
Elo Clinical Research
Maringa, PA 87015-200
BrazilSite Not Available
Centro Integrado de Oncologia de Curitiba
Curitiba, PR 80810-050
BrazilSite Not Available
Hrpc - Health Clinical Research Representation - Eireli
Canoas, RS 92010-170
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande Do Sul 90035-903
BrazilSite Not Available
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Fundação Doutor Amaral Carvalho
JAU, SP 17210-120
BrazilSite Not Available
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, SP 09060-650
BrazilSite Not Available
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Santa Catarina 89201-260
BrazilSite Not Available
Hospital das Clínicas FMRP-USP
Ribeirao Preto, São Paulo 14048-900
BrazilSite Not Available
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo Andre, São Paulo 09060-870
BrazilSite Not Available
Hospital Paulistano
Sao Paulo, São Paulo 01321-000
BrazilSite Not Available
Hospital Sírio-Libanês
Sao Paulo, São Paulo 01308-050
BrazilSite Not Available
Beneficencia Portuguesa de Sao Paulo
São Paulo, 01321-00
BrazilSite Not Available
CISSS Chaudière-Appalaches
Levis, Quebec G6V 3Z1
CanadaSite Not Available
CHUQ - Hôtel-Dieu de Québec
Ste-Foy, Quebec G1V 4G2
CanadaSite Not Available
Fundacion Santa Fe de Bogota
Bogota, 110111
ColombiaSite Not Available
Hospital Pablo Tobon Uribe
Medellin, 050034
ColombiaSite Not Available
Ustav hematologie a krevni transfuze
Praha, 128 00
CzechiaSite Not Available
North Estonia Medical Centre Foundation
Tallinn, 13419
EstoniaSite Not Available
Hopital Claude Huriez - CHU Lille
Lille, 59037
FranceSite Not Available
Hopital Claude Huriez - CHU Lille
Lille cedex, 59037
FranceSite Not Available
Institut Paoli Calmette; Service d'Hématologie Clinique
Marseille, 13273
FranceSite Not Available
CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique
Rennes cedex 9, 35033
FranceSite Not Available
Universitaetsklinikum Aachen AOeR
Aachen, 52074
GermanySite Not Available
Universitaetsklinikum
Duesseldorf, 40225
GermanySite Not Available
Universitaetsklinikum
Essen, 45147
GermanySite Not Available
ELBLANDKLINIKUM Riesa
Riesa, 01589
GermanySite Not Available
Universitaetsklinikum Ulm
Ulm, 89081
GermanySite Not Available
Attikon University General Hospital
Ahens, 124 64
GreeceSite Not Available
University General Hospital of Alexandroupolis
Alexandroupolis, 681 00
GreeceSite Not Available
Attikon University General Hospital
Athens, 124 62
GreeceSite Not Available
General Hospital of Athens LAIKO
Athens, 115 27
GreeceSite Not Available
Attikon University General Hospital
Chaidari, 124 62
GreeceSite Not Available
University General Hospital of Larissa
Larissa, 412 21
GreeceSite Not Available
AHEPA General Hospital of Thessaloniki
Thessaloniki, 546 36
GreeceSite Not Available
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki, 57010
GreeceSite Not Available
General Hospital of Athens LAIKO
Αθηνα, 115 27
GreeceSite Not Available
The Chinese University of Hong Kong
Shatin, DUMMY_VALUE
Hong KongSite Not Available
Semmelweis Egyetem
Budapest, 1088
HungarySite Not Available
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Budapest, 1088
HungarySite Not Available
St James's Hospital
Dublin, D08X4RX
IrelandSite Not Available
Rambam Health Care Center
Haifa, 91096
IsraelSite Not Available
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Campania 83100
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania 80131
ItalySite Not Available
Azienda Unita Sanitaria Locale- Ravenna
Ravenna, Emilia-Romagna 48121
ItalySite Not Available
Azienda Ospedaliera Sant'Andrea
Roma, Lazio 00189
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio 00168
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio 00168
ItalySite Not Available
Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico
Milano, Lombardia 20122
ItalySite Not Available
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte 10126
ItalySite Not Available
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicilia 95123
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana 50134
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Florence, Toscana 50134
ItalySite Not Available
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto 36100
ItalySite Not Available
Fujita Health University Hospital
Aichi, 470-1192
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima, 960-1295
JapanSite Not Available
Sapporo Medical University Hospital
Hokkaido, 060-8543
JapanSite Not Available
Kobe University Hospital
Hyogo, 650-0017
JapanSite Not Available
Kobe University Hospital; Medical Oncology and Hematology
Hyogo, 650-0017
JapanSite Not Available
Tokushukai Takasago Seibu Hospital
Hyogo, 676-0812
JapanSite Not Available
University of Tsukuba Hospital
Ibaraki, 305-8576
JapanSite Not Available
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530
JapanSite Not Available
Tokai University Hospital
Kanagawa, 259-1193
JapanSite Not Available
Mie University Hospital
Mie, 514-8507
JapanSite Not Available
Fukushima Medical University Hospital
Miyagi, 960-1295
JapanSite Not Available
Japanese Red Cross Society Suwa Hospital
Nagano, 392-8510
JapanSite Not Available
Nagasaki University Hospital
Nagasaki, 852-8501
JapanSite Not Available
Sasebo City General Hospital
Nagasaki, 857-8511
JapanSite Not Available
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
JapanSite Not Available
Osaka University Hospital
Osaka, 565-0871
JapanSite Not Available
Iwate Prefectural Isawa Hospital
Oshu, 023-0864
JapanSite Not Available
NTT Medical Center Tokyo
Tokyo, 141-8625
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanSite Not Available
Toyama Prefectual Central Hospital
Toyama, 930-8550
JapanSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital; Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan, 44033
Korea, Republic ofSite Not Available
Global Trial Research Center S.A. de C.V.
Monterrey, Nuevo LEON 64718
MexicoSite Not Available
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Radboudumc
NL -nijmegen, 6525 GA
NetherlandsSite Not Available
Szpital Uniwersytecki nr2 im. dr J. Biziela
Bydgoszcz, 85-168
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gda?sk, 80-214
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, 80-952
PolandSite Not Available
SPZOZ Szpital Uniw W Krakowie
Krakow, 31-501
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, 20-081
PolandSite Not Available
Centrum Medyczne Pratia Poznan
Skórzewo, 60-185
PolandSite Not Available
MTZ Clinical Research Powered by Pratia
Warszawa, 02-172
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, 44803
PolandSite Not Available
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro
Aveiro, 3814-501
PortugalSite Not Available
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001
PortugalSite Not Available
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
Saudi ArabiaSite Not Available
National University Hospital
Singapore, 117599
SingaporeSite Not Available
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 826 06
SlovakiaSite Not Available
Hospital Universitario Central de Asturias
Oviedo, Asturias 33011
SpainSite Not Available
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 08916
SpainSite Not Available
ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica
Badalona, Barcelona 08916
SpainSite Not Available
Hospital Sant Joan De Deu
Esplugues De Llobregas, Barcelona 08950
SpainSite Not Available
Complejo Hospitalario Universitario de Santiago.
Santiago de Compostela, LA Coruna 15706
SpainSite Not Available
Hospital Universitario de Gran Canaria
Las Palmas de Gran Canaria, LAS Palmas 35019
SpainSite Not Available
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital de Basurto
Bilbao, Vizcaya 48013
SpainSite Not Available
Hospital U. Central de Asturias
Asturias, 33011
SpainSite Not Available
Hospital Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital San Pedro de Alcantara
Caceres, 10003
SpainSite Not Available
Hospital Universitario de Gran Canaria
Las Palmas, 35010
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hospital Universitario Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Regional Universitario de Malaga
Malaga, 29010
SpainSite Not Available
Hospital Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Complejo Hospitalario de Toledo
Toledo, 45004
SpainSite Not Available
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Akademiska Sjukhuset
Uppsala, 751 85
SwedenSite Not Available
Changhua Christian Hospital
Chang Hua, 500
TaiwanSite Not Available
Hualien Tzu Chi Hospital
Hualien, DUMMY_VALUE
TaiwanSite Not Available
Hualien Tzu Chi Hospital; Hematology and oncology
Hualien,
TaiwanSite Not Available
Hualien Tzu Chi Hospital; Hematology and oncology
Hualien City, 97002
TaiwanSite Not Available
Chi Mei Medical Center Liou Ying Campus
Liuying Township, 736
TaiwanSite Not Available
MacKay Memorial Hospital; Hematology and oncology
Taipei, 10449
TaiwanActive - Recruiting
National Taiwan Universtiy Hospital
Taipei, 100
TaiwanSite Not Available
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, 100
TaiwanSite Not Available
MacKay Memorial Hospital; Hematology and oncology
Zhongshan Dist., 10449
TaiwanSite Not Available
Hacettepe University Medical Faculty; Neurology
Ankara, 06100
TurkeySite Not Available
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology
Gaziantep, 27310
TurkeySite Not Available
Istanbul University Istanbul Medical Faculty; Neurology
Istanbul, 34093
TurkeySite Not Available
Marmara University Pendik Training and Research Hospital, Hematology Department
Istanbul, 34300
TurkeySite Not Available
Ege University Medical Faculty; Hematology
Izmir, 35040
TurkeySite Not Available
Ondokuz Mayis Univ. Med. Fac.
Samsun, 55139
TurkeySite Not Available
Monklands Hospital; Haematology
Airdrie, ML6 0JS
United KingdomSite Not Available
St James's Institute of Oncology; Dept of Haematology
Leeds, LS9 7TF
United KingdomSite Not Available
King'S College Hospital
London, SE5 9RS
United KingdomSite Not Available
King'S College Hospital; Haematology
London, SE5 9RS
United KingdomSite Not Available
University of Arizona
Tucson, Arizona 85724
United StatesSite Not Available
The Oncology Institute of Hope and Innovation
Anaheim, California 92801
United StatesSite Not Available
University of California Irvine
Irvine, California 92697
United StatesSite Not Available
David Geffen School of Medicine UCLA
Los Angeles, California 90095
United StatesSite Not Available
University of Florida College of Medicine
Gainesville, Florida 32610
United StatesSite Not Available
Indiana Blood & Marrow Transplantation, LLC
Indianapolis, Indiana 46237
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United StatesSite Not Available
Henry Ford Hospital; Henry Ford Medical Center
West Bloomfield, Michigan 48322
United StatesSite Not Available
Upstate University Hospital; SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
Carolinas Healthcare System
Charlotte, North Carolina 28204
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Nationwide Children's Hospital; Dept. of Pulmonology
Columbus, Ohio 43205
United StatesSite Not Available
Cook Childrens Medical Center
Fort Worth, Texas 76104
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin 53226-3596
United StatesSite Not Available
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