Phase
Condition
Sickle Cell Disease
Red Blood Cell Disorders
Treatment
Inclacumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who meet all the following criteria will be eligible for study enrollment:
Male or female participant with SCD who participated and received study drug in aGBT-Sponsored inclacumab clinical study.
Participant has completed the originating inclacumab study within 30 calendar daysof the Day 1 Visit. Participants who discontinued study drug in the originatingstudy due to a non-study drug-related AE, but who remained on study, may be eligiblefor treatment in this study provided the AE does not pose a risk for treatment withinclacumab.
Female participants of childbearing potential are required to have a negative urinepregnancy test prior to dosing on Day 1. Note: Female participants who become of childbearing potential during the study mustbe willing to have a negative urine pregnancy test to remain in the study.
If sexually active, female participants of childbearing potential must consistentlyuse highly effective methods of contraception consistently throughout the study andfor at least 165 days after the last dose of study drug. If sexually active, maleparticipants must use barrier methods of contraception until 165 days after the lastdose of study drug.
Participant has provided written informed consent/assent. For underage participants,both the consent of the participant's legal representative or legal guardian and theparticipant's assent (where applicable) must be obtained based on local requirement.
Exclusion
Exclusion Criteria:
Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:
Female participant who is breastfeeding or pregnant.
Participant had an infusions-related reaction (IRR) in the originating inclacumabclinical study.
Participant withdrew consent from the originating inclacumab clinical study.
Participant was lost to follow-up from the originating inclacumab clinical study.
Participant has any medical, psychological, safety, or behavioral conditions that,in the opinion of the Investigator, may confound safety interpretation, interferewith compliance, or preclude informed consent.
Study Design
Study Description
Connect with a study center
Instituto D'Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Bahia 41253-190
BrazilSite Not Available
Hemocentro de Belo Horizonte - Fundacao Hemominas
Belo Horizonte, MG 30130-110
BrazilSite Not Available
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais 30130-100
BrazilSite Not Available
Multihemo Servicos Medicos S/A
Recife, PE 50070-460
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, RIO Grande DO SUL 90035-903
BrazilSite Not Available
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Sao Jose do Rio Preto, SAO Paulo 15090-000
BrazilSite Not Available
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, SÃO Paulo 14051-140
BrazilSite Not Available
Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIO
Rio de Janeiro, 20211-030
BrazilSite Not Available
CEPEC-Centro de Pesquisa Clinica
São Paulo, 08270-120
BrazilSite Not Available
Casa de Saude Santa Marcelina
São Paulo, 08270-070
BrazilSite Not Available
Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.A
São Paulo, 01232-010
BrazilSite Not Available
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSP
São Paulo, 05403-000
BrazilSite Not Available
Clinica de la Costa Ltda.
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Sociedad de Oncología y hematología del Cesar
Valledupar, Cesar 200001
ColombiaSite Not Available
Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation
Regensburg, 93053
GermanySite Not Available
Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali Galliera
Genova, 16128
ItalySite Not Available
S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferro
Genova, 16128
ItalySite Not Available
DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi Vanvitel
Napoli, 80138
ItalySite Not Available
UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
Napoli, 80138
ItalySite Not Available
UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, 80138
ItalySite Not Available
UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
Napoli, 80138
ItalySite Not Available
Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
Padova, 35128
ItalySite Not Available
Farmacia Azienda Ospedale Universita Padova
Padova, 35128
ItalySite Not Available
U.O.C. Farmacia Istituto Oncologico Veneto
Padova, 35128
ItalySite Not Available
KEMRI/CRDR Siaya Clinical Research Annex
Kisumu, Siaya 40600
KenyaSite Not Available
International Cancer Institute
Eldoret, 30100
KenyaSite Not Available
International Cancer Institute (ICI)
Eldoret, 30100
KenyaSite Not Available
Gertrude's Children's Hospital
Nairobi, 00100
KenyaSite Not Available
KEMRI CRDR Clinical Research Clinic Nairobi
Nairobi,
KenyaSite Not Available
Kenya Medical Research Institute - Centre for Respiratory Disease Research
Nairobi, 00100
KenyaSite Not Available
Strathmore University CREATES
Nairobi, 00200
KenyaSite Not Available
KEMRI/CRDR Siaya Clinical Research Annex
Siaya,
KenyaSite Not Available
American University of Beirut Medical Center
Hamra, Beirut
LebanonSite Not Available
Nini Hospital
Tripoli, North Lebanon
LebanonSite Not Available
American University of Beirut Medical Center
Beirut,
LebanonSite Not Available
University of Calabar Teaching Hospital
Calabar, Cross River State 540242
NigeriaSite Not Available
National Hospital Abuja
Abuja, FCT 900211
NigeriaSite Not Available
University of Abuja Teaching Hospital
Gwagwalada, FCT 902101
NigeriaSite Not Available
Ahmadu Bello University Teaching Hospital
Zaria, Kaduna 810105
NigeriaSite Not Available
University of Nigeria Teaching Hospital
Enugu, 460000
NigeriaSite Not Available
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, 800212
NigeriaSite Not Available
Aminu Kano Teaching Hospital
Kano, 700223
NigeriaSite Not Available
Department of Pediatrics, College of Medicine, Lagos University Teaching Hospital
Lagos, 100254
NigeriaSite Not Available
Lagos University Teaching Hospital Haematology
Suru Lere,
NigeriaSite Not Available
Sultan Qaboos University Hospital
Muscat, 123
OmanSite Not Available
Prince Mohammed bin Nasser Hospital
Jizan, Southern 82943
Saudi ArabiaSite Not Available
NIMR-Mbeya Medical Research Center
Mbeya,
TanzaniaSite Not Available
Acibadem Adana Hastanesi Cocuk Hematoloji Onkoloji
Adana, 01130
TurkeySite Not Available
Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital Hematology
Adana, 01250
TurkeySite Not Available
Baskent University Medical Faculty Adana Practice and Research Center
Adana, 01250
TurkeySite Not Available
Hacettepe University Ihsan Dogramaci Children Hospital
Ankara, 06430
TurkeySite Not Available
Hacettepe University Ihsan Dogramaci Children's Ho
Ankara, 06230
TurkeySite Not Available
Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi Hastanesi
Mersin, 33343
TurkeySite Not Available
Strada Patient Care Center, Pediatric Hematology
Mobile, Alabama 36604
United StatesSite Not Available
University of South Alabama Children's and Women's Hospital
Mobile, Alabama 36604
United StatesSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
Children's Hospital and Research Center at Oakland
Oakland, California 94609-1809
United StatesSite Not Available
UC Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
UConn-Neag Comprehensive Cancer Center
Farmington, Connecticut 06030
United StatesSite Not Available
John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)
Tampa, Florida 33612
United StatesSite Not Available
St. Joseph's Hospital
Tampa, Florida 33607
United StatesSite Not Available
USF Health Carol and Frank Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesSite Not Available
USF Health South Tampa Center for Advanced Healthcare (STC)
Tampa, Florida 33606
United StatesSite Not Available
University of South Florida, Department of Pediatrics
Tampa, Florida 33606
United StatesSite Not Available
University of Illinois Hospital and Health Sciences System (UI Health)
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois Hospital and Health Systems
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago
Chicago, Illinois 60612
United StatesSite Not Available
University of Illinois at Chicago (UIC) Clinical Research Center
Chicago, Illinois 60612
United StatesSite Not Available
Brigham And Woman's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute IDS Pharmacy
Boston, Massachusetts 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan 48109
United StatesSite Not Available
Jacobi Medical Center
Bronx, New York 10461
United StatesSite Not Available
Erie Country Medical Center
Buffalo, New York 14215
United StatesSite Not Available
DUMC Investigational Drug Services Pharmacy
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
McGovern Medical School at UTHealth
Houston, Texas 77030
United StatesSite Not Available
UT Health Science Center at Houston - Clinical Research Unit at Memorial Hermann Hospital
Houston, Texas 77030
United StatesSite Not Available
UT Physicians Comprehensive Sickle Cell Center Houston
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030-1501
United StatesSite Not Available
University of Texas Health Science Center of Houston -6410 Fannin St Ste 600
Houston, Texas 77030-1501
United StatesSite Not Available
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