72
Participants
Start Date
December 9, 2021
Primary Completion Date
November 24, 2023
Study Completion Date
November 24, 2023
Inclacumab
Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
Placebo
Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug.
Sultan Qaboos University Hospital, Muscat
Matero Clinical Research Site,, Lusaka
University Teaching Hospital- Children's Hospital, Lusaka
Jacobi Medical Center, The Bronx
Erie County Medical Center, Buffalo
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera, Genova
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro, Genova
PPD Bioanalytical, Richmond
Duke University Medical Center, Durham
DUMC Investigational Drug Services Pharmacy, Durham
International Cancer Institute, Eldoret
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi, Yenischir, Mersin
St. Joseph's Hospital, Tampa
Strada Patient Care Center, Mobile
University of South Alabama Children's and Women's Hospital, Mobile
University of South Alabama Mitchell Cancer Institute, Mobile
St. Jude Children's Research Hospital, Memphis
Kemri/Crdr, Siaya, Kemri Clinical Research Annex,, Kisumu
University of Michigan Hospitals - Michigan Medicine, Ann Arbor
Functional Fluidics, Inc., Detroit
Arkansas Children's Hospital, Little Rock
"DAI Materno-Infantile, UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria Luigi Vanvitell", Napoli
UO di Farmacia Clinica, Dipartimento di Medicina Sperimentale Azienda Ospedaliera Universitaria, Napoli
"UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria Luigi Vanvitelli", Napoli
"UOC Radiologia Azienda Ospedaliera Universitaria Luigi Vanvitelli", Napoli
Prince Mohammed bin Nasser Hospital, Jizan
Phoenix Children's Hospital, Phoenix
Alliance for Childhood Diseases dba Cure 4 The Kids Foundation, Las Vegas
Children's Hospital of Orange County, Orange
Hopital Avicenne, Bobigny
Universitatsklinikum Regensburg Padiatrische Hamatologie, Onkologie und Stammzelltransplantation, Regensburg
Hopital Henri Mondor, Créteil
UCSF Benioff Children's Hospital, Oakland, Oakland
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital, Lagos
University of Nigeria Teaching Hospital, Enugu
University of Calabar Teaching Hospital, Calabar
Aminu Kano Teaching Hospital, Kano
Barau Dikko Teaching Hospital/Kaduna State University, Kaduna
Ahmadu Bello University Teaching Hospital (ABUTH), Zaria
National Hospital Abuja, Abuja
University of Abuja Teaching Hospital, Gwagwalada
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael, Salvador
Multihemo Servicos Medicos S/A, Recife
Hospital de Clinicas de Porto Alegre, Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto
Casa de Saude Santa Marcelina, São Paulo
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti - HEMORIO, Rio de Janeiro
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP, São Paulo
CEPEC-Centro de Pesquisa Clinica, São Paulo
Clinica de la Costa Ltda., Barranquilla
Organizacion Clinica Bonnadona Prevenir S.A.S., Barranquilla
Kenya medical Research Institute-centre for Respiratory Disease Research, Nairobi
Strathmore University Medical Center - Center for Research in Therapeutic Sciences(CREATES), Nairobi
American University of Beirut Medical Center, Hamra
Nini Hospital, Tripoli
Hacettepe University, Ankara
Baskent University Hospital, Adana
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji, Adana
Guy's & Thomas' NHS Foundation Trust, London
Lead Sponsor
Pfizer
INDUSTRY