A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease
Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-occlusive Pain Episode in Sickle Cell Disease
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring blood disorders, hemoglobin, red blood cells, RBCs, sickle-like shape, mutation in hemoglobin gene, Sickle Cell Disease, SCD, Vaso-occlusive Crisis, VOC, SCA, Open Label
Eligibility Criteria
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 a GBT-Sponsored inclacumab clinical study.
- Participant has completed the originating inclacumab study within 30 calendar days of the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab.
Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
Note: Female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study.
- If sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose 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 the participant's assent (where applicable) must be obtained based on local requirement.
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 inclacumab clinical 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, interfere with compliance, or preclude informed consent.
Sites / Locations
- Strada Patient Care Center, Pediatric HematologyRecruiting
- University of South Alabama Children's and Women's HospitalRecruiting
- Arkansas Children's HospitalRecruiting
- Children's Hospital and Research Center at OaklandRecruiting
- UC Irvine Medical CenterRecruiting
- University of South Florida, Department of PediatricsRecruiting
- USF Health South Tampa Center for Advanced Healthcare (STC)Recruiting
- St. Joseph's HospitalRecruiting
- John S Curran,MD, Children's Health Center/Children's Medical Center (CMS)Recruiting
- USF Health Carol and Frank Morsani Center for Advanced HealthcareRecruiting
- University of Illinois at ChicagoRecruiting
- University of Illinois Hospital and Health SystemsRecruiting
- Brigham And Woman's HospitalRecruiting
- Dana-Farber Cancer Institute IDS PharmacyRecruiting
- Dana-Farber Cancer InstituteRecruiting
- University of Michigan Hospitals - Michigan MedicineRecruiting
- Jacobi Medical CenterRecruiting
- Erie Country Medical CenterRecruiting
- Duke University Medical CenterRecruiting
- DUMC Investigational Drug Services PharmacyRecruiting
- Instituto D'Or de Pesquisa e Ensino - Hospital São RafaelRecruiting
- Hemocentro de Belo Horizonte - Fundacao HemominasRecruiting
- Hospital das Clinicas da Universidade Federal de Minas GeraisRecruiting
- Multihemo Servicos Medicos S/ARecruiting
- Hospital de Clínicas de Porto AlegreRecruiting
- Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
- Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USPRecruiting
- Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti - HEMORIORecruiting
- Hospital Samaritano Higienópolis/Esho Empresa De Servicos Hospitalares S.ARecruiting
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo -HCFMUSPRecruiting
- Clinica de la Costa Ltda.Recruiting
- Sociedad de Oncología y hematología del CesarRecruiting
- Universitätsklinikum Regensburg Pädiatrische Hämatologie, Onkologie und StammzelltransplantationRecruiting
- Farmacia Interna Azienda Ospedaliero-Ente Ospedaliero Ospedali GallieraRecruiting
- S.S.D. Microcitemia, anemie congenite e dismetabolismo del ferroRecruiting
- DAI Materno-Infantile,- UOC Clinica Pediatrica 1 Azienda Ospedaliera Universitaria "Luigi VanvitelRecruiting
- UO di Farmacia Clinica,Dipartimento di Medicina Sperimentale
- UO di Farmacia Clinica,Dipartimento di Medicina SperimentaleRecruiting
- UOC Patologia Clinica e Molecolare Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
- UOC Radiologia Azienda Ospedaliera Universitaria "Luigi Vanvitelli"Recruiting
- Dipartimento Strutturale Aziendale Salute della Donna e del Bambino Clinica Ginecologica
- Farmacia Azienda Ospedale Universita Padova
- U.O.C. Farmacia Istituto Oncologico Veneto
- KEMRI/CRDR Siaya Clinical Research AnnexRecruiting
- International Cancer InstituteRecruiting
- Kenya Medical Research Institute - Centre for Respiratory Disease ResearchRecruiting
- Strathmore University CREATESRecruiting
- American University of Beirut Medical CenterRecruiting
- Nini HospitalRecruiting
- University of Calabar Teaching Hospital
- National Hospital AbujaRecruiting
- University of Abuja Teaching Hospital
- Ahmadu Bello University Teaching Hospital
- Aminu Kano Teaching Hospital
- Department of Pediatrics, College of Medicine, Lagos University Teaching HospitalRecruiting
- Sultan Qaboos University HospitalRecruiting
- Prince Mohammed bin Nasser HospitalRecruiting
- NIMR-Mbeya Medical Research CenterRecruiting
- Acibadem Adana Hastanesi Cocuk Hematoloji OnkolojiRecruiting
- Baskent University Adana Appl. and Research Central, Yuregir Baskent Hospital HematologyRecruiting
- Hacettepe University Ihsan Dogramaci Children HospitalRecruiting
- Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Merkezi HastanesiRecruiting
Arms of the Study
Arm 1
Experimental
Inclacumab 30 mg/kg
Inclacumab 30 mg/kg administered intravenously (IV)