Die Wirksamkeit und Sicherheit von Elritercept bei erwachsenen Teilnehmern mit sehr geringem, geringem oder mittlerem Risiko für myelodysplastische Syndrome (MDS) mit Anämie (RENEW)
Eine randomisierte, doppelblinde, placebokontrollierte Phase-3-Studie zur Bewertung der Wirksamkeit und Sicherheit von Elritercept (KER-050) zur Behandlung transfusionsabhängiger Anämie bei erwachsenen Teilnehmern mit sehr geringem, geringem oder mittlerem Risiko Myelodysplastische Syndrome (MDS) (RENEW)
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of elritercept (TAK-226, KER-050) versus placebo. Elritercept (TAK-226, KER-050) is an investigational medicinal product being developed for the treatment of anemia in adult participants with a diagnosis of lower-risk myelodysplastic neoplasms/syndromes. After all required Screening Period assessments are completed, and eligibility is confirmed, participants will be randomized and enter the Primary Phase of the Double-Blind Treatment Period. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept (TAK-226, KER-050) or placebo subcutaneously (SC) every 4 weeks (Q4W). Participants will be stratified according to their ring sideroblasts (RS) status (RS-positive versus non-RS) and baseline transfusion burden (low-transfusion burden [LTB] versus high transfusion burden [HTB]). The Primary Phase of the Double-blind Treatment Period will last 24 weeks. The Secondary Phase of the Double-Blind Treatment Period will last an additional 24 weeks. During the Secondary Phase of the Double-Blind Treatment Period, all participants will continue to receive the same double-blind treatment they received during the Primary Phase. Study visits will occur approximately every 2 weeks from Cycle 1 through Cycle 6 and every 4 weeks from Cycle 7 through the remainder of the Double-Blind Treatment Period. During the Extension Phase of the Double-Blind Treatment Period, all eligible participants will continue to receive the same double-blind treatment they received during the Primary and Secondary Phases. Participants will continue in the Extension Phase until they individually discontinue or until the study is unblinded. For participants to remain on double-blind treatment, they must meet the criteria outlined in the MDS disease assessment criteria every 24 weeks. Based on the outcome of the Week 24 MDS disease assessment, participants will either continue in the Extension Phase of the Double-blind Treatment Period or will be discontinued from treatment and proceed to End of Treatment and then into the Safety Follow-up Period. The Safety Follow-Up Period will extend from the last dose of study treatment through 8 weeks after the last dose of study treatment. Study visits should occur every 4 weeks within the Safety Follow-Up Period. Long-term follow-up will take place quarterly after a participant has completed the Safety Follow-Up Period. Long-term follow-up will continue for 5 years from the first dose of study treatment, or until a participant is deceased, is lost to follow-up, withdraws consent, or the study closes, whichever is earliest.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 3
Kontakte und Standorte
Studienkontakt
- Name: Takeda Contact
- Telefonnummer: +1-877-825-3327
- E-Mail: medinfoUS@takeda.com
Studienorte
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Australian Capital Territory
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Garran, Australian Capital Territory, Australien, 2605
- Noch keine Rekrutierung
- The Canberra Hospital
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Hauptermittler:
- Philip Choi
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Kontakt:
- Site Contact
- E-Mail: phil.choi@act.gov.au
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New South Wales
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Sydney, New South Wales, Australien, 2145
- Rekrutierung
- Westmead Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +61 () 424275524
- E-Mail: lachlin.vaughan@health.nsw.gov.au
-
Hauptermittler:
- Lachlin Vaughan
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Queensland
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Douglas, Queensland, Australien, 4814
- Rekrutierung
- Townsville University Hospital
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Hauptermittler:
- Joel Wight
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Kontakt:
- Site Contact
- Telefonnummer: 61-7-4433-1111
- E-Mail: Joel.Wight@health.qld.gov.au
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekrutierung
- Royal Adelaide Hospital
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Kontakt:
- Site Contact
- Telefonnummer: +61 (8) 8222 3369
- E-Mail: Devendra.hiwase@sa.gov.au
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Hauptermittler:
- Devendra Hiwase
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Adelaide, South Australia, Australien, 5042
- Rekrutierung
- Flinders Medical Centre
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Kontakt:
- Site Contact
- Telefonnummer: +61 (8) 8222 4000
- E-Mail: Ashanka.Beligaswatte@sa.gov.au
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Hauptermittler:
- Ashanka Beligaswatte
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Victoria
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Box Hill, Victoria, Australien, 3128
- Rekrutierung
- Box Hill Hospital
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Kontakt:
- Site Contact
- Telefonnummer: +61 (3) 8396 8442
- E-Mail: genevieve.douglas@easternhealth.org.au
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Hauptermittler:
- Genevieve Douglas
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Fitzroy, Victoria, Australien, 3065
- Rekrutierung
- St Vincent's Hospital (Melbourne) Ltd
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Kontakt:
- Site Contact
- Telefonnummer: 61-3-9231-2211
- E-Mail: ShuhYing.TAN@svha.org.au
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Hauptermittler:
- ShuhYing Tan
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Melbourne, Victoria, Australien, 3004
- Noch keine Rekrutierung
- Alfred Health
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Hauptermittler:
- Shaun Fleming
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Kontakt:
- Site Contact
- E-Mail: shaun.fleming1@monash.edu
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Parkville, Victoria, Australien, 3000
- Rekrutierung
- Peter MacCallum Cancer Center
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Kontakt:
- Site Contact
- Telefonnummer: +61 (0) 3 8559 5000
- E-Mail: Lynette.Chee@mh.org.au
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Hauptermittler:
- Lynette Chee
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-
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Rio de Janeiro, Brasilien, 22775-001
- Rekrutierung
- Americas Institute
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Hauptermittler:
- Fernando Correia Pinto
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Kontakt:
- Site Contact
- Telefonnummer: 21-3385-2000
- E-Mail: fernandomonteiro@americasoncologia.com.br
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São Paulo, Brasilien, 01323-900
- Rekrutierung
- Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
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Kontakt:
- Site Contact
- Telefonnummer: +55 (11) 3505 6615
- E-Mail: scheinbp@gmail.com
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Hauptermittler:
- Phillip Scheinberg
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São Paulo, Brasilien, 01509-900
- Rekrutierung
- Hospital A.C.Camargo ("Antonio Prudente" Foundation)
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Hauptermittler:
- Marina Nascimento
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Kontakt:
- Site Contact
- Telefonnummer: 55-11-9-9901-3833
- E-Mail: marina.nascimento@accamargo.org.br
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São Paulo, Brasilien, 11075-900
- Rekrutierung
- Santa Casa of Mercy of Santos
-
Hauptermittler:
- Elaine Mancilha
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Kontakt:
- Site Contact
- Telefonnummer: 13-3221-5508
- E-Mail: elaine_mancilha@hotmail.com
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Paraná
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Curitiba, Paraná, Brasilien, 81520-060
- Rekrutierung
- Hosptial Erasto Gaertner
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Kontakt:
- Site Contact
- E-Mail: drciliao@gmail.com
-
Hauptermittler:
- Eduardo Munhoz
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Rekrutierung
- Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
-
Hauptermittler:
- Mariza Schaan
-
Kontakt:
- Site Contact
- Telefonnummer: 55-51-3320-3660
- E-Mail: mzschaan@hotmail.com
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Rekrutierung
- Porto Alegre Clinical Hospital (HCPA)
-
Hauptermittler:
- Laura Maria Fogliatto
-
Kontakt:
- Site Contact
- Telefonnummer: 55-51-3359-8000
- E-Mail: fogliattopesquisa@gmail.com
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Porto Alegre, Rio Grande do Sul, Brasilien, 90110-270
- Rekrutierung
- Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
-
Hauptermittler:
- Marcelo Capra
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Kontakt:
- Site Contact
- Telefonnummer: +55 (51) 33789927
- E-Mail: marcelocapra@hotmail.com
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Santa Catarina
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Joinville, Santa Catarina, Brasilien, 89201-260
- Rekrutierung
- Instituto Joinvilense de Hematologia e Oncologia
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Kontakt:
- Site Contact
- E-Mail: marcelolacerda001@gmail.com
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Hauptermittler:
- Lacerda Marcelo
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São Paulo
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Jaú, São Paulo, Brasilien, 17210-080
- Rekrutierung
- FundaAAo Doutor Amaral Carvalho
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Kontakt:
- Site Contact
- E-Mail: pesquisafac.edersonmattos@gmail.com
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Hauptermittler:
- Guilherme Mattos
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Santo André, São Paulo, Brasilien, 09060-650
- Rekrutierung
- Cepho- Fmabc
-
Kontakt:
- Site Contact
- E-Mail: vitormauad.medabc@gmail.com
-
Hauptermittler:
- Vitor Mauad
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São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Rekrutierung
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
-
Hauptermittler:
- Mariana Buka
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Kontakt:
- Site Contact
- Telefonnummer: 55-17-3201-5000
- E-Mail: marianabuka@outlook.com
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-
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Plovdiv, Bulgarien, 4002
- Rekrutierung
- Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
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Kontakt:
- Site Contact
- Telefonnummer: +359 (32) 602 298
- E-Mail: penchogeorgiev@yahoo.com
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Hauptermittler:
- Pencho Georgiev
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Sofia, Bulgarien, 1431
- Rekrutierung
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
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Hauptermittler:
- Atanas Radinoff
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Kontakt:
- Site Contact
- Telefonnummer: 359-52-978-288
- E-Mail: aradinoff@hotmail.com
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Sofia, Bulgarien, 1606
- Rekrutierung
- Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
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Kontakt:
- Site Contact
- Telefonnummer: +359 (884) 674 160
- E-Mail: viktoriia1982@abv.bg
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Hauptermittler:
- Viktoria Barbukova
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Sofia, Bulgarien, 1797
- Rekrutierung
- Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
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Kontakt:
- Site Contact
- Telefonnummer: +359 (898) 719 792
- E-Mail: drtanyayankova@gmail.com
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Hauptermittler:
- Tanya Yankova
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Varna, Bulgarien, 9010
- Noch keine Rekrutierung
- University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
-
Hauptermittler:
- Ilina Micheva
-
Kontakt:
- Site Contact
- Telefonnummer: +359 (52) 978 288
- E-Mail: IlinaMichevailinamicheva@gmail.com
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-
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Santiago, Chile, 7500653
- Rekrutierung
- SAGA Clinical Research Center SpA
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Hauptermittler:
- Ada Hernandez
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Kontakt:
- Site Contact
- Telefonnummer: 56-9-8326-9755
- E-Mail: ahernandez@cecsaga.cl
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Santiago, Chile, 7580206
- Rekrutierung
- Clinic Inmunocel
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Kontakt:
- Site Contact
- E-Mail: jvinuela@inmunocel.com
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Hauptermittler:
- Jose Vinuela
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Santiago, Chile, 8320000
- Rekrutierung
- Center for Clinical Studies and Medical Research (CECIM)
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Hauptermittler:
- Alexander Arellano
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Kontakt:
- Site Contact
- Telefonnummer: 56-9-5826-3308
- E-Mail: alexander.arellano@cecim.cl
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Biobio
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Concepción, Biobio, Chile, 4070356
- Rekrutierung
- Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
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Hauptermittler:
- Monica Romero
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Kontakt:
- Site Contact
- Telefonnummer: 56-41-272-2500
- E-Mail: mpromero@hospitalinfantildesanjose.org.co
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- Rekrutierung
- IC La Serena Research
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Hauptermittler:
- Cleiden Villegas
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Kontakt:
- Site Contact
- Telefonnummer: 56-51-286127
- E-Mail: cleiden.villegas@iclsr.cl
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-
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Berlin, Deutschland, 10715
- Rekrutierung
- Praxis am Volkspark Berlin
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Hauptermittler:
- Jan-Piet Habbel
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Kontakt:
- Site Contact
- Telefonnummer: 49-30-84723535
- E-Mail: jp.habbel@praxis-am-volkspark-berlin.de
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Berlin, Deutschland, 12203
- Rekrutierung
- Charite Universitatsmedizin Berlin
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Hauptermittler:
- Kathrin Rieger
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Kontakt:
- Site Contact
- Telefonnummer: +49 (30) 450 513 535
- E-Mail: kathrin.rieger@charite.de
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Deutschland, 53127
- Noch keine Rekrutierung
- University Hospital Bronn
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Hauptermittler:
- Karin Mayer
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Kontakt:
- Site Contact
- Telefonnummer: 49-228-2870
- E-Mail: karin.mayer@ukb.uni-bonn.de
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Düsseldorf, North Rhine-Westphalia, Deutschland, 40479
- Rekrutierung
- Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
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Kontakt:
- Site Contact
- Telefonnummer: +49 (211) 4400 2501
- E-Mail: Aristoteles.giagounidis@vkkd-kliniken.de
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Hauptermittler:
- Aristoteles Giagounidis
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Saxony
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Leipzig, Saxony, Deutschland, 04103
- Rekrutierung
- University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
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Hauptermittler:
- Dominic Brauer
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Kontakt:
- Site Contact
- Telefonnummer: 49-341-9713081
- E-Mail: Dominic.Brauer@medizin.uni-leipzig.de
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Deutschland, 06120
- Rekrutierung
- University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
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Kontakt:
- Site Contact
- Telefonnummer: +49 (345) 557 3080
- E-Mail: haifa.al-ali@uk-halle.de
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Hauptermittler:
- Haifa Al-Ali
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Magdeburg, Saxony-Anhalt, Deutschland, 39120
- Noch keine Rekrutierung
- University Clinic of Hematology, Oncology and Cell Therapy
-
Hauptermittler:
- Berisha Mirjeta
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Kontakt:
- Site Contact
- Telefonnummer: 646-501-0194
- E-Mail: mirjeta.berisha@med.ovgu.de
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Nice, Frankreich, 06200
- Rekrutierung
- Archet 1 and 2 hospital
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Hauptermittler:
- Thomas Cluzeau
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Kontakt:
- Site Contact
- Telefonnummer: +33 (4) 9203 7777
- E-Mail: cluzeau.t@chu-nice.fr
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Paris, Frankreich, 75010
- Rekrutierung
- Saint-Louis Hospital
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Hauptermittler:
- Lionel Ades
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Kontakt:
- Site Contact
- Telefonnummer: +33 (1) 7120 7021
- E-Mail: lionel.ades@aphp.fr
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Poitiers, Frankreich, 86000
- Rekrutierung
- Poitiers University Hospital Center - Miletrie Site
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Hauptermittler:
- Jose Miguel Torregrosa-Diaz
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Kontakt:
- Site Contact
- Telefonnummer: +33 (5) 4944 5415
- E-Mail: Jose-Miguel.Torregrosa-Diaz@chu-poitiers.fr
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Toulouse, Frankreich, 31059
- Rekrutierung
- IUCT-Oncopole
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Kontakt:
- Site Contact
- Telefonnummer: +33 (531) 156 266
- E-Mail: Comont.Thibault@iuct-oncopole.fr
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Hauptermittler:
- Thibault Comont
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Delhi, Indien, 110085
- Noch keine Rekrutierung
- Rajiv Gandhi Cancer Institute & Research Centre
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Kontakt:
- Site Contact
- Telefonnummer: 9971500861
- E-Mail: Bhurani@gmail.com
-
Hauptermittler:
- Dinesh Bhurani
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Gūrgaon, Indien, 122018
- Rekrutierung
- Medanta the Medicity
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Kontakt:
- Site Contact
- Telefonnummer: 9717265111
- E-Mail: nitin.sood@medanta.org
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Hauptermittler:
- Nitin Sood
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Gujarat
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Ahmedabad, Gujarat, Indien, 380009
- Rekrutierung
- Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
-
Kontakt:
- Site Contact
- Telefonnummer: 9824041170
- E-Mail: sandip60@yahoo.com
-
Hauptermittler:
- Sandip Shah
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Ahmedabad, Gujarat, Indien, 382428
- Rekrutierung
- Apollo Hospital International Ltd
-
Kontakt:
- Site Contact
- Telefonnummer: 9920273063
- E-Mail: profvelunair@gmail.com
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Hauptermittler:
- Velu Nair
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Kerala
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Ernākulam, Kerala, Indien, 682041
- Noch keine Rekrutierung
- Amrita Institute of Medical Sciences
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Kontakt:
- Site Contact
- Telefonnummer: 9946047464
- E-Mail: neerajsidharthan@aims.amrita.edu
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Hauptermittler:
- Neeraj Siddharthan
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Maharashtra
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Mumbai, Maharashtra, Indien, 400012
- Noch keine Rekrutierung
- Tata Memorial Centre
-
Kontakt:
- Site Contact
- Telefonnummer: 9632006180
- E-Mail: dralokshetty@gmail.com
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Hauptermittler:
- Alok Shetty
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-
National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indien, 110029
- Rekrutierung
- All India Institute of Medical Science
-
Kontakt:
- Site Contact
- Telefonnummer: 911126588499
- E-Mail: drtulikaseth@gmail.com
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Hauptermittler:
- Tulika Seth
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Punjab
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Ludhiana, Punjab, Indien, 380006
- Rekrutierung
- Christian Medical College, Ludhianana
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Kontakt:
- Site Contact
- Telefonnummer: 8054959525
- E-Mail: mjosephjohn@gmail.com
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Hauptermittler:
- Joseph John
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Tamil Nadu
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Vellore, Tamil Nadu, Indien, 632004
- Rekrutierung
- Christian Medical College
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Kontakt:
- Site Contact
- Telefonnummer: 4172224553
- E-Mail: biju@cmcvellore.ac.in
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Hauptermittler:
- Biju George
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Uttar Pradesh
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Ghaziabad, Uttar Pradesh, Indien, 201012
- Noch keine Rekrutierung
- Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
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Kontakt:
- Site Contact
- Telefonnummer: 9451405842
- E-Mail: pradeep.kumar9@maxhealthcare.com
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Hauptermittler:
- Pradeep Kumar
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West Bengal
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Kolkata, West Bengal, Indien, 700014
- Rekrutierung
- NRS Medical College and Hospital
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Kontakt:
- Site Contact
- Telefonnummer: 9874890275
- E-Mail: tkdolai@hotmail.com
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Hauptermittler:
- Tuphan Kanti Dolai
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Kolkata, West Bengal, Indien, 700156
- Rekrutierung
- Tata Medical Center, Kolkata
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Kontakt:
- Site Contact
- Telefonnummer: 3366057620
- E-Mail: arijit.nag@tmckolkata.com
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Hauptermittler:
- Arijit Nag
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Cork, Irland, T12 DC4A
- Rekrutierung
- Cork University Hospital
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Hauptermittler:
- Vitaliy Mykytiv
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Kontakt:
- Site Contact
- Telefonnummer: 353-21-492-2000
- E-Mail: Vitaliy.mykytiv@hse.ie
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Dublin, Irland, D07 R2WY
- Rekrutierung
- Mater Misericordiae University Hospital
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Hauptermittler:
- Su Maung
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Kontakt:
- Site Contact
- Telefonnummer: 353-1-803-2000
- E-Mail: SuMaung@mater.ie
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Dublin, Irland, D24 NR0A
- Rekrutierung
- Tallaght University Hospital
-
Hauptermittler:
- Helen Enright
-
Kontakt:
- Site Contact
- Telefonnummer: 353-1-221-4000
- E-Mail: Helen.Enright@tuh.ie
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Dublin, Irland, D05 DK31
- Rekrutierung
- Beaumont Hospital
-
Hauptermittler:
- Philip Murphy
-
Kontakt:
- Site Contact
- Telefonnummer: +353 (1) 809 2373
- E-Mail: philipmurphy@beaumont.ie
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Dublin, Irland, DO4 T6F4
- Rekrutierung
- St Vincent's University Hospital (SVUH)
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Hauptermittler:
- Claire Andrews
-
Kontakt:
- Site Contact
- Telefonnummer: 353-1-221-4000
- E-Mail: claireandrews@st-vincents.ie
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Limerick, Irland, V94 F858
- Rekrutierung
- University Hospital Limerick
-
Kontakt:
- Site Contact
- Telefonnummer: +353 (877) 385 852
- E-Mail: cian.mcellistrim@hse.ie
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Hauptermittler:
- Cian McEllistrim
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Jerusalem, Israel, 9112001
- Rekrutierung
- Hadassah Medical Center, Department of Hematology
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Kontakt:
- Site Contact
- Telefonnummer: +972 (2) 677 6748
- E-Mail: sabanre@hadassah.org.il
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Hauptermittler:
- Revital Saban
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Petah Tikva, Israel, 49100
- Rekrutierung
- Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
-
Hauptermittler:
- Ofir Wolach
-
Kontakt:
- Site Contact
- Telefonnummer: +972 (3) 937 8116
- E-Mail: owolach@gmail.com
-
Ramat Gan, Israel, 5266202
- Rekrutierung
- Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
-
Hauptermittler:
- Drorit Merkel
-
Kontakt:
- Site Contact
- Telefonnummer: +972 (3) 530 5213
- E-Mail: Drorit.Merkel@sheba.health.gov.il
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Tel Aviv, Israel, 6423906
- Rekrutierung
- The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
-
Hauptermittler:
- Yakir Moshe
-
Kontakt:
- Site Contact
- Telefonnummer: 972-3-697-4444
- E-Mail: yakirm@tlvmc.gov.il
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Florence, Italien, 50134
- Rekrutierung
- Careggi University Hospital
-
Hauptermittler:
- Valeria Santini
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (55) 794 7296
- E-Mail: valeria.santini@unifi.it
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Milan, Italien, 20122
- Rekrutierung
- Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
-
Hauptermittler:
- Bruno Fattizzo
-
Kontakt:
- Site Contact
- Telefonnummer: 02-5503-4422
- E-Mail: bruno.fattizzo@policlinico.mi.it
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Pavia, Italien, 27100
- Rekrutierung
- Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (382) 503 062
- E-Mail: luca.malcovati@unipv.it
-
Hauptermittler:
- Luca Malcovati
-
Reggio Calabria, Italien, 89133
- Rekrutierung
- Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
-
Kontakt:
- Site Contact
- E-Mail: caterina.alati@gmail.com
-
Hauptermittler:
- Caterina Alati
-
Rome, Italien, 00133
- Rekrutierung
- Foundation PTV - Polyclinic Tor Vergata
-
Hauptermittler:
- Maria Teresa Voso
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (6) 2090 3210
- E-Mail: mtvoso@rm.unicatt.it
-
Rozzano, Italien, 20089
- Rekrutierung
- Clinical Institute Humanitas, IRCCS
-
Hauptermittler:
- Matteo Giovanni Della Porta
-
Kontakt:
- Site Contact
- Telefonnummer: 39-02-82241
- E-Mail: matteo.della_porta@hunimed.eu
-
Turin, Italien, 10060
- Rekrutierung
- Institute of Cancer Research and Treatment of Candiolo
-
Hauptermittler:
- Elena Crisa
-
Kontakt:
- Site Contact
- Telefonnummer: 39-011-993-3111
- E-Mail: elena.crisa@ircc.it
-
-
AN
-
Ancona, AN, Italien, 60126
- Rekrutierung
- Aou Delle Marche
-
Hauptermittler:
- Antonella Poloni
-
Kontakt:
- Site Contact
- E-Mail: a.poloni@staff.univpm.it
-
-
Piedmont
-
Turin, Piedmont, Italien, 10128
- Rekrutierung
- AO Ordine Mauriziano
-
Hauptermittler:
- Daniela Cilloni
-
Kontakt:
- Site Contact
- E-Mail: daniela.cilloni@unito.it
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 2B7
- Rekrutierung
- University of Alberta Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (780) 407 1584
- E-Mail: yannancy@ualberta.ca
-
Hauptermittler:
- Nancy Zhu
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V6Z 2A5
- Rekrutierung
- Providence Hematology - Vancouver
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (604) 684 5794
- E-Mail: hleitch@pacifichematology.ca
-
Hauptermittler:
- Heather Leitch
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 1V7
- Rekrutierung
- Nova Scotia Health Authority, Centre for Clinical Research
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (902) 473 3498
- E-Mail: amy2.trottier@nshealth.ca
-
Hauptermittler:
- Amy Trottier
-
-
Ontario
-
London, Ontario, Kanada, N6A 4L6
- Rekrutierung
- London Health Sciences Centre
-
Hauptermittler:
- Lalit Saini
-
Kontakt:
- Site Contact
- Telefonnummer: 519-685-8380
- E-Mail: Lalit.Saini@lhsc.on.ca
-
Toronto, Ontario, Kanada, M5G 2M9
- Rekrutierung
- Princess Margaret Cancer Centre
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (416) 946 4501
- E-Mail: Karen.Yee@uhn.ca
-
Hauptermittler:
- Karen Yee
-
Toronto, Ontario, Kanada, M4N 3M5
- Rekrutierung
- Sunnybrook Research Institute, Odette Cancer Center
-
Hauptermittler:
- Rena Buckstein
-
Kontakt:
- Site Contact
- Telefonnummer: +416 (480) 5847
- E-Mail: Rena.Buckstein@sunnybrook.ca
-
-
-
-
-
Kaunas, Litauen, LT-50161
- Rekrutierung
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
-
Kontakt:
- Site Contact
- Telefonnummer: +370 (614) 84 658
- E-Mail: milda.rudzianskiene@gmail.com
-
Hauptermittler:
- Milda Rudzianskiene
-
Vilnius, Litauen, LT-08406
- Rekrutierung
- Vilnius University Hospital Santaros Klinikos
-
Hauptermittler:
- Andrius Degulys
-
Kontakt:
- Site Contact
- Telefonnummer: 370-5-250-1717
- E-Mail: andrius.degulys@santa.lt
-
-
-
-
-
Bellavista, Peru, 07016
- Noch keine Rekrutierung
- Daniel Alcides Carrion National Hospital
-
Hauptermittler:
- Jose Chinen Pemberton
-
Kontakt:
- Site Contact
- Telefonnummer: 997-889-111
- E-Mail: joserevi7@yahoo.com
-
Lima, Peru, 15038
- Noch keine Rekrutierung
- National Institute of Neoplastic Diseases
-
Kontakt:
- Site Contact
- Telefonnummer: +51 (942) 136-304
- E-Mail: jufravas1ro@hotmail.com
-
Hauptermittler:
- Jule Vasquez
-
-
Jesus Maria
-
Lima, Jesus Maria, Peru, 15073
- Noch keine Rekrutierung
- Edgardo Rebagliati Martins National Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +51 (987) 245-661
- E-Mail: lourdesaranda@gmail.com
-
Hauptermittler:
- Lourdes Aranda
-
-
La Molina
-
Lima, La Molina, Peru, 15023
- Rekrutierung
- Anglo American Clinic
-
Hauptermittler:
- Antonio Carrasco
-
Kontakt:
- Site Contact
- Telefonnummer: 51-1-6168900
- E-Mail: antonio1carrasco@hotmail.com
-
-
San Isidro Lima
-
Lima, San Isidro Lima, Peru, 02002
- Rekrutierung
- IPOR: Peruvian Institute of Oncology & Radiotherapy
-
Hauptermittler:
- Maria Vera Vasquez
-
Kontakt:
- Site Contact
- Telefonnummer: 51-1-2241779
- E-Mail: maria.vera.vasquez1@gmail.com
-
-
-
-
-
Katowice, Polen, 40-519
- Rekrutierung
- Pratia Oncology Katowice
-
Hauptermittler:
- Sebastian Grosicki
-
Kontakt:
- Site Contact
- Telefonnummer: 48-501-714-019
- E-Mail: sebastian.grosicki@pratia.com
-
Lodz, Polen, 93-513
- Rekrutierung
- Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
-
Hauptermittler:
- Tadeusz Robak
-
Kontakt:
- Site Contact
- Telefonnummer: +48 (42) 689 5191
- E-Mail: robaktad@csk.umed.lodz.pl
-
Olsztyn, Polen, 10-228
- Rekrutierung
- Clinical Hospital Of The Ministry Of Internal Affairs And Administration With Warmia And Mazury Oncology Centre In Olsztyn, Clinical Department of Hematology and Internal Medicine with Bone Marrow Transplantation Center
-
Hauptermittler:
- Janusz Halka
-
Kontakt:
- Site Contact
- Telefonnummer: + (48) 602 120 684
- E-Mail: janusz.halka@poliklinika.net
-
-
Greater
-
Poznan, Greater, Polen, 60-192
- Rekrutierung
- Pratia Poznan
-
Kontakt:
- Site Contact
- E-Mail: anna.hoppe@pratia.com
-
Hauptermittler:
- Anna Hoppe
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 50-019
- Rekrutierung
- Pratia Onkologia Wroclaw
-
Kontakt:
- Site Contact
- E-Mail: rybka.justyna@o2.pl
-
Hauptermittler:
- Justyna Rybka
-
-
-
-
-
Lund, Schweden, 221 85
- Rekrutierung
- Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
-
Kontakt:
- Site Contact
- Telefonnummer: +46 (46) 171 000
- E-Mail: lars.nilsson@skane.se
-
Hauptermittler:
- Lars Nilsson
-
-
A-rebro County
-
Örebro, A-rebro County, Schweden, 70185
- Noch keine Rekrutierung
- A-rebro University Hospital, Hematology Department
-
Kontakt:
- Site Contact
- E-Mail: bengt.rasmussen@regionorebrolan.se
-
Hauptermittler:
- Bengt Rasmussen
-
-
Stockholm County
-
Huddinge, Stockholm County, Schweden, 141 57
- Rekrutierung
- Karolinska University Hospital
-
Hauptermittler:
- Magnus Tobiasson
-
Kontakt:
- Site Contact
- Telefonnummer: 46-8-123-700000
- E-Mail: magnus.tobiasson@ki.se
-
-
VG
-
Gothenburg, VG, Schweden, 41345
- Noch keine Rekrutierung
- Sahlgrenska University Hospital
-
Kontakt:
- Site Contact
- E-Mail: lena.von.bahr@vgregion.se
-
Hauptermittler:
- Lena Von Bahr
-
-
-
-
-
Bern, Schweiz, 3010
- Noch keine Rekrutierung
- Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
-
Kontakt:
- Site Contact
- E-Mail: natalia.baran@insel.ch
-
Hauptermittler:
- Natalia Baran
-
Zurich, Schweiz, 8091
- Rekrutierung
- Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
-
Kontakt:
- Site Contact
- E-Mail: stefan.balabanov@usz.ch
-
Hauptermittler:
- Stefan Balabanov
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Schweiz, 4031
- Noch keine Rekrutierung
- University Hosptial Basel
-
Kontakt:
- Site Contact
- E-Mail: gregor.stehle@usb.ch
-
Hauptermittler:
- Gregor Stehle
-
-
-
-
Castille and León
-
Salamanca, Castille and León, Spanien, 37007
- Rekrutierung
- University Clinical Hospital of Salamanca, Department of Hematology
-
Hauptermittler:
- Maria Diez Campelo
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (923) 291 100
- E-Mail: mdiezcampelo@usal.es
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08035
- Rekrutierung
- University Hospital Vall d'Hebron, Department of Hematology
-
Hauptermittler:
- David Valcarcel Ferreiras
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (932) 746 100
- E-Mail: dvalcarcel@vhio.net
-
-
Girona
-
L'Hospitalet de Llobregat, Girona, Spanien, 08908
- Rekrutierung
- Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
-
Hauptermittler:
- Montserrat Arnan Sangerman
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (932) 607 750
- E-Mail: marnan@iconcologia.net
-
-
Madrid
-
Madrid, Madrid, Spanien, 28034
- Rekrutierung
- University Hospital Ramon y Cajal
-
Hauptermittler:
- Kyra Velazquez Kennedy
-
Kontakt:
- Site Contact
- Telefonnummer: 34-913-36-8000
- E-Mail: kyra.vkennedy@gmail.com
-
Madrid, Madrid, Spanien, 28040
- Rekrutierung
- University Hospital Foundation Jimenez Diaz
-
Hauptermittler:
- Teresa Arquero Portero
-
Kontakt:
- Site Contact
- Telefonnummer: 34-915-50-4800
- E-Mail: tarquero@fjd.es
-
-
Valencia
-
Valencia, Valencia, Spanien, 46026
- Rekrutierung
- University and Polytechnic Hospital La Fe
-
Hauptermittler:
- Elvira Mora Castera
-
Kontakt:
- Site Contact
- Telefonnummer: 34-961-24-4000
- E-Mail: mora_elv@gva.es
-
-
-
-
-
Cape Town, Südafrika, 7580
- Rekrutierung
- Haemalife
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (21) 581 0717
- E-Mail: michael.cass@haemalife.co.za
-
Hauptermittler:
- Michael Cass
-
Durban, Südafrika, 4091
- Rekrutierung
- Capital Haematology Hospital
-
Hauptermittler:
- Jaimendra Singh
-
Kontakt:
- Site Contact
- Telefonnummer: 27-31-832-9700
- E-Mail: jaimendra.singh@gmail.com
-
Johannesburg, Südafrika, 2193
- Rekrutierung
- Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (11) 489 8413
- E-Mail: johnny.mahlangu@nhls.ac.za
-
Hauptermittler:
- Johnny Mahlangu
-
Pretoria, Südafrika, 0181
- Rekrutierung
- Alberts Cellular Therapy
-
Hauptermittler:
- Andrew McDonald
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (12) 993 2555
- E-Mail: andrew@actlife.co.za
-
-
-
-
-
Daegu, Südkorea, 41944
- Rekrutierung
- Kyungpook National University Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (53) 200 5570
- E-Mail: jhmoon74@knuh.kr
-
Hauptermittler:
- Joon ho Moon
-
Seoul, Südkorea, 05505
- Rekrutierung
- Asan Medical Center
-
Hauptermittler:
- Je-Hwan Lee
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 3010 3218
- E-Mail: jhlee3@amc.seoul.kr
-
Seoul, Südkorea, 03080
- Rekrutierung
- Seoul National University Hospital
-
Hauptermittler:
- Junshik Hong
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 2072-0834
- E-Mail: hongjblood@snu.ac.kr
-
Seoul, Südkorea, 06351
- Rekrutierung
- Samsung Medical Center
-
Hauptermittler:
- Jun Ho Jang
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 3410 0918
- E-Mail: smcjunhojang@gmail.com
-
Seoul, Südkorea, 04401
- Rekrutierung
- Soon Chun Hyang University Hospital Seoul
-
Hauptermittler:
- Seug Yun Yoon
-
Kontakt:
- Site Contact
- Telefonnummer: 82-2-709-9144
- E-Mail: ysy6496@schmc.ac.kr
-
Seoul, Südkorea, 06591
- Rekrutierung
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Hauptermittler:
- Yoo Jin Kim
-
Kontakt:
- Site Contact
- Telefonnummer: 82-1588-1511
- E-Mail: yoojink@catholic.ac.kr
-
-
-
-
-
Taichung, Taiwan, 407219
- Rekrutierung
- Taichung Veterans General Hospital
-
Hauptermittler:
- Cheng-Hsien Lin
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-2359-2525
- E-Mail: briefsummer@gmail.com
-
Tainan, Taiwan, 704302
- Rekrutierung
- National Cheng Kung University Hospital
-
Hauptermittler:
- Tsai-Yun Chen
-
Kontakt:
- Site Contact
- Telefonnummer: +886 (6) 235 3535
- E-Mail: teresa@mail.ncku.edu.tw
-
Taipei, Taiwan, 100225
- Rekrutierung
- National Taiwan University Hospital
-
Hauptermittler:
- Wen-Chien Chou
-
Kontakt:
- Site Contact
- Telefonnummer: 886-2-2312-3456
- E-Mail: wchou@ntu.edu.tw
-
Taoyuan City, Taiwan, 333
- Rekrutierung
- Linkou Chang Gung Memorial Hospital
-
Hauptermittler:
- Ming-Chung Kuo
-
Kontakt:
- Site Contact
- Telefonnummer: 886-3-328-1200
- E-Mail: kmc12069@gmail.com
-
-
Changhua County
-
Changhua, Changhua County, Taiwan, 500209
- Rekrutierung
- Changhua Christian Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-723-8595
- E-Mail: 155627@cch.org.tw
-
Hauptermittler:
- Ruo-Han Tseng
-
Changhua, Changhua County, Taiwan, 50544
- Rekrutierung
- Chang Bing Show Chwan Memorial Hospital
-
Hauptermittler:
- Cheng-Shyong Chang
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-781-3888
- E-Mail: cs4816@gmail.com
-
-
-
-
-
Bangkok, Thailand, 10330
- Rekrutierung
- King Chulalongkorn Memorial Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 251 6704
- E-Mail: drnoppacharn@yahoo.com
-
Hauptermittler:
- Noppacharn Uaprasert
-
Bangkok, Thailand, 10400
- Rekrutierung
- Ramathibodi Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 201 2373
- E-Mail: Nickero059@hotmail.com
-
Hauptermittler:
- Piyajaroenkij Thanakrit
-
Bangkok, Thailand, 10400
- Rekrutierung
- Rajavithi Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 206 2900
- E-Mail: kunapa@gmail.com
-
Hauptermittler:
- Kunapa Iam-arunthai
-
Bangkok, Thailand, 74210
- Rekrutierung
- Banphaeo General Hospital
-
Hauptermittler:
- Busakorn Sae-Aeng
-
Kontakt:
- Site Contact
- Telefonnummer: 034-419555-6
- E-Mail: Himatologist55@gmail.com
-
Chiang Mai, Thailand, 50200
- Rekrutierung
- Maharaj Nakorn Chiangmai Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (53) 945 482
- E-Mail: thanawat_r@outlook.com
-
Hauptermittler:
- Thanawat Rattanathammethee
-
-
-
-
-
Brno, Tschechien, 625 00
- Rekrutierung
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
-
Hauptermittler:
- Jiri Mayer
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 532 231 111
- E-Mail: Mayer.Jiri@fnbrno.cz
-
Hradec Králové, Tschechien, 500 05
- Rekrutierung
- University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 495 833 837
- E-Mail: petra.belohlavkova@fnhk.cz
-
Hauptermittler:
- Petra Belohlavkova
-
Ostrava, Tschechien, 70852
- Rekrutierung
- Charles University General Hospital
-
Hauptermittler:
- Anna Jonasova
-
Kontakt:
- Site Contact
- E-Mail: anna.jonasova@vfn.cz
-
Ostrava, Tschechien, 70852
- Rekrutierung
- University Hospital Ostrava and Faculty of Medicine, University of Ostrava
-
Kontakt:
- Site Contact
- E-Mail: barbora.dluhosova@fno.cz
-
Hauptermittler:
- Zdenek Koristek
-
Prague, Tschechien, 100 00
- Rekrutierung
- University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 267 162 887
- E-Mail: olga.cerna@fnkv.cz
-
Hauptermittler:
- Olga Cerna
-
Prague, Tschechien, 12800
- Rekrutierung
- Institute of Hematology and Blood Transfusion, Division of Training and Development
-
Hauptermittler:
- Marketa Stastna-Markova
-
Kontakt:
- Site Contact
- Telefonnummer: 420-221-977-296
- E-Mail: marketa.markova@uhkt.cz
-
-
-
-
-
Adana, Türkei (türkiye), 01370
- Rekrutierung
- Adana City Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (542) 630 8353
- E-Mail: elifsuyani@hotmail.com
-
Hauptermittler:
- Elif Suyani
-
Ankara, Türkei (türkiye), 06170
- Rekrutierung
- Ankara Etlik City Hospital
-
Hauptermittler:
- Merih Kizil Cakar
-
Kontakt:
- Site Contact
- Telefonnummer: 90-362-312-1919
- E-Mail: merihkizil@yahoo.com
-
Ankara, Türkei (türkiye), 06600
- Noch keine Rekrutierung
- Ankara University Medical Faculty Cebeci Hospital
-
Hauptermittler:
- Selami Toprak
-
Kontakt:
- Site Contact
- Telefonnummer: 90-312-595-6000
- E-Mail: sktoprak@yahoo.com
-
Antalya, Türkei (türkiye), 07100
- Rekrutierung
- Antalya Education and Training Hospital
-
Hauptermittler:
- Volkan Karakus
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (505) 765 6778
- E-Mail: dr_v_karakus@yahoo.com
-
Mersin, Türkei (türkiye), 33200
- Rekrutierung
- Mersin Medicalpark Hospital
-
Hauptermittler:
- Anil Tombak
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (532) 346 0767
- E-Mail: aniltombak@hotmail.com
-
Sakarya, Türkei (türkiye), 54290
- Rekrutierung
- Sakarya University Medical Faculty Hospital
-
Hauptermittler:
- Cenk Sunu
-
Kontakt:
- Site Contact
- Telefonnummer: 90-4445400
- E-Mail: SunuCenk@gmail.com
-
Samsun, Türkei (türkiye), 55139
- Rekrutierung
- Ondokuz Mayis University School of Medicine, Department of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (505) 272 2289
- E-Mail: engink@omu.edu.tr
-
Hauptermittler:
- Engin Kelkitli
-
-
-
-
-
Budapest, Ungarn, H-1088
- Rekrutierung
- Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
-
Hauptermittler:
- Zsolt Nagy
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (20) 825 8660
- E-Mail: nagy.zsolt@med.semmelweis-univ.hu
-
Debrecen, Ungarn, 4032
- Rekrutierung
- University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
-
Hauptermittler:
- Arpad Illes
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (52) 255 480
- E-Mail: illesarpaddr@gmail.com
-
Kaposvár, Ungarn, H-7400
- Rekrutierung
- Mor Kaposi General Hospital, Department of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (82) 501 363
- E-Mail: dregyedmiklos@yahoo.com
-
Hauptermittler:
- Miklos Egyed
-
Nyíregyháza, Ungarn, 4400
- Rekrutierung
- Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
-
Hauptermittler:
- Laszlo Rejto
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (42) 599 719
- E-Mail: lrejto@med.unideb.hu
-
Székesfehérvár, Ungarn, H-8000
- Rekrutierung
- Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (20) 970 9318
- E-Mail: aszomor@clinics.pote.hu
-
Hauptermittler:
- Arpad Szomor
-
-
-
-
California
-
Duarte, California, Vereinigte Staaten, 91010
- Rekrutierung
- City of Hope
-
Hauptermittler:
- Andrew Artz
-
Kontakt:
- Site Contact
- Telefonnummer: 626-218-2404
- E-Mail: aartz@coh.org
-
Glendale, California, Vereinigte Staaten, 91206
- Rekrutierung
- Los Angeles Cancer Network
-
Hauptermittler:
- Eric Lee
-
Kontakt:
- Site Contact
- Telefonnummer: 215-707-7312
- E-Mail: eric.lee@lahomg.com
-
La Jolla, California, Vereinigte Staaten, 92037
- Rekrutierung
- UC San Diego Moores Cancer Center
-
Hauptermittler:
- Amanda Kagan
-
Kontakt:
- Site Contact
- Telefonnummer: 858-822-6100
- E-Mail: amanda.kagan@jhmi.edu
-
-
Connecticut
-
New Haven, Connecticut, Vereinigte Staaten, 06511
- Rekrutierung
- Smilow Cancer Hospital at Yale-New Haven
-
Hauptermittler:
- Amer Zeidan
-
Kontakt:
- Site Contact
- Telefonnummer: 203-737-7103
- E-Mail: amer.zeidan@yale.edu
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33136
- Rekrutierung
- University of Miami Hospital and Clinics
-
Kontakt:
- Site Contact
- Telefonnummer: 305-243-9974
- E-Mail: msekeres@med.miami.edu
-
Hauptermittler:
- Mikkael Sekeres
-
Tampa, Florida, Vereinigte Staaten, 33612
- Rekrutierung
- Moffitt Cancer Center
-
Kontakt:
- Site Contact
- Telefonnummer: 888-860-2778
- E-Mail: rami.komrokji@moffitt.org
-
Hauptermittler:
- Rami Komrokji
-
-
Illinois
-
Peoria, Illinois, Vereinigte Staaten, 61645
- Rekrutierung
- ILCC. Illinois Cancer Centers
-
Kontakt:
- Site Contact
- Telefonnummer: 309-240-6388
- E-Mail: paul.fishkin@usoncology.com
-
Hauptermittler:
- Paul Fishkin
-
-
Kentucky
-
Louisville, Kentucky, Vereinigte Staaten, 40207
- Rekrutierung
- Norton Cancer Institute
-
Hauptermittler:
- Don Stevens
-
Kontakt:
- Site Contact
- Telefonnummer: 502-906-7543
- E-Mail: Don.Stevens@nortonhealthcare.org
-
-
Louisiana
-
Monroe, Louisiana, Vereinigte Staaten, 71201
- Rekrutierung
- Ghattas Oncology
-
Hauptermittler:
- Tharwat Ghattas
-
Kontakt:
- Site Contact
- E-Mail: tghattas@epicmedresearch.com
-
-
Maryland
-
Columbia, Maryland, Vereinigte Staaten, 21044
- Rekrutierung
- Maryland Oncology Hematolofy
-
Hauptermittler:
- Mohit Narang
-
Kontakt:
- Site Contact
- Telefonnummer: 410-581-2100
- E-Mail: mohit.narang@usoncology.com
-
-
Missouri
-
Kansas City, Missouri, Vereinigte Staaten, 64132
- Rekrutierung
- MidAmerica Cancer Care
-
Kontakt:
- Site Contact
- Telefonnummer: 816-974-5050
- E-Mail: benjamin.fangman@aoncology.com
-
Hauptermittler:
- Benjamin Fangman
-
-
Nevada
-
Henderson, Nevada, Vereinigte Staaten, 89169
- Rekrutierung
- Comprehensive Cancer Centers of Nevada
-
Hauptermittler:
- Edwin Kingsley
-
Kontakt:
- Site Contact
- Telefonnummer: 702-952-3444
- E-Mail: edwin.kingsley@usoncology.com
-
-
New York
-
Westbury, New York, Vereinigte Staaten, 11590
- Rekrutierung
- Clinical Research Alliance NY
-
Hauptermittler:
- Jonathan Goldberg
-
Kontakt:
- Site Contact
- Telefonnummer: 516-488-2918
- E-Mail: jgoldberg@caremount.com
-
-
North Carolina
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27013
- Rekrutierung
- Novant Health-Cancer Institute
-
Hauptermittler:
- James Dugan
-
Kontakt:
- Site Contact
- Telefonnummer: 336-718-5570
- E-Mail: jpdugan@novanthealth.org
-
-
Ohio
-
Canton, Ohio, Vereinigte Staaten, 44718
- Rekrutierung
- Gabrail Cancer Center Research
-
Hauptermittler:
- Nashat Gabrail
-
Kontakt:
- Site Contact
- Telefonnummer: 330-492-3345
- E-Mail: research@gabrailcancercenter.com
-
Cleveland, Ohio, Vereinigte Staaten, 44195
- Rekrutierung
- Cleveland Clinic - Cleveland
-
Kontakt:
- Site Contact
- Telefonnummer: 216-445-7942
- E-Mail: jaina9@ccf.org
-
Hauptermittler:
- Akriti Jain
-
-
Tennessee
-
Knoxville, Tennessee, Vereinigte Staaten, 37909
- Rekrutierung
- Tennessee Cancer Specialists
-
Kontakt:
- Site Contact
- Telefonnummer: 865-934-5800
- E-Mail: tracy.dobbs@tncancer.com
-
Hauptermittler:
- Tracy Dobbs
-
Nashville, Tennessee, Vereinigte Staaten, 37232
- Rekrutierung
- Vanderbilt University Medical Center
-
Hauptermittler:
- Ashwin Kishtagari
-
Kontakt:
- Site Contact
- Telefonnummer: 615-322-5000
- E-Mail: Ashwin.Kishtagari@vumc.org
-
-
Texas
-
Denison, Texas, Vereinigte Staaten, 75020
- Rekrutierung
- Texas Oncology Northeast Texas
-
Hauptermittler:
- Amir Faridi
-
Kontakt:
- Site Contact
- Telefonnummer: 903-868-4700
- E-Mail: amir.faridi@texasoncology.com
-
Houston, Texas, Vereinigte Staaten, 77090
- Rekrutierung
- LUMI Research
-
Hauptermittler:
- David Nguyen
-
Kontakt:
- Site Contact
- E-Mail: dmnguyen@lumiresearch.com
-
Houston, Texas, Vereinigte Staaten, 77030
- Rekrutierung
- U.T. MD Anderson Cancer Center, Division of Cancer Medicine
-
Hauptermittler:
- Guillermo Garcia-Manero
-
Kontakt:
- Site Contact
- Telefonnummer: 713-792-6161
- E-Mail: ggarciam@mdanderson.org
-
Red Oak, Texas, Vereinigte Staaten, 75154
- Rekrutierung
- Epic Medical Research
-
Hauptermittler:
- Kirtan Koticha
-
Kontakt:
- Site Contact
- E-Mail: kkoticha@epicmedresearch.com
-
The Woodlands, Texas, Vereinigte Staaten, 77380
- Rekrutierung
- Texas Oncology Gulf Coast
-
Hauptermittler:
- Andrew Jackson
-
Kontakt:
- Site Contact
- Telefonnummer: 409-938-8600
- E-Mail: andrew.jackson@usoncology.com
-
Webster, Texas, Vereinigte Staaten, 77598-4085
- Rekrutierung
- Tranquil Research
-
Hauptermittler:
- John Knecht
-
Kontakt:
- Site Contact
- Telefonnummer: 713-907-6054
- E-Mail: drknecht@cls.health
-
-
Washington
-
Issaquah, Washington, Vereinigte Staaten, 98029
- Noch keine Rekrutierung
- Epic Care Emeryville
-
Kontakt:
- Site Contact
- E-Mail: behlr@sutterhealth.org
-
Hauptermittler:
- Rajesh Behl
-
-
-
-
-
Birmingham, Vereinigtes Königreich, B15 2TH
- Rekrutierung
- Queen Elizabeth Hospital Birmingham
-
Hauptermittler:
- Vidhya Murthy
-
Kontakt:
- Site Contact
- Telefonnummer: 44-121-627-2000
- E-Mail: Vidhya.Murthy2@uhb.nhs.uk
-
Cambridge, Vereinigtes Königreich, CB2 0QQ
- Rekrutierung
- Addenbrooke's Hospital
-
Hauptermittler:
- Duncan Brian
-
Kontakt:
- Site Contact
- Telefonnummer: 44-1223-805000
- E-Mail: duncanbrian@nhs.net
-
Leeds, Vereinigtes Königreich, LS9 7TF
- Rekrutierung
- St James's University Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 44-113-243-3144
- E-Mail: catherine.cargo@nhs.net
-
Hauptermittler:
- Catherine Cargo
-
London, Vereinigtes Königreich, SE5 9RS
- Rekrutierung
- King's College Hospital
-
Hauptermittler:
- Austin Kulasekararaj
-
Kontakt:
- Site Contact
- Telefonnummer: +44 (79) 6768 6823
- E-Mail: austin.kulasekararaj@nhs.net
-
London, Vereinigtes Königreich, W1G 6AD
- Rekrutierung
- Sarah Cannon Research Institute (SCRI)
-
Hauptermittler:
- Jennifer O'Sullivan (Dillon)
-
Kontakt:
- Site Contact
- Telefonnummer: 615-329-7274
- E-Mail: jenniferosullivan@nhs.net
-
Manchester, Vereinigtes Königreich, M20 4BX
- Rekrutierung
- The Christie NHS Foundation Trust
-
Hauptermittler:
- Daniel Wiseman
-
Kontakt:
- Site Contact
- Telefonnummer: 44-161-446-3000
- E-Mail: daniel.wiseman@nhs.net
-
Nottingham, Vereinigtes Königreich, NG5 1PB
- Rekrutierung
- Nottingham City Hospital
-
Hauptermittler:
- Jennifer Byrne
-
Kontakt:
- Site Contact
- Telefonnummer: 44-115-969-1169
- E-Mail: Jennifer.Byrne@nuh.nhs.uk
-
Oxford, Vereinigtes Königreich, OX3 7LE
- Rekrutierung
- Churchill Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 44-300-304-7777
- E-Mail: Oni.Chowdhury@ouh.nhs.uk
-
Hauptermittler:
- Oni Chowdhury
-
-
Aberdeen City
-
Aberdeen, Aberdeen City, Vereinigtes Königreich, AB25 2ZN
- Rekrutierung
- Aberdeen Royal Infirmary
-
Hauptermittler:
- Dominic Culligan
-
Kontakt:
- Site Contact
- E-Mail: dominic.culligan@nhs.scot
-
-
Denbighshire
-
Rhyl, Denbighshire, Vereinigtes Königreich, LL18 5UJ
- Rekrutierung
- Glan Clwyd Hospital
-
Hauptermittler:
- Earnest Heartin
-
Kontakt:
- Site Contact
- E-Mail: earnest.heartin@wales.nhs.uk
-
-
Leics
-
Leicester, Leics, Vereinigtes Königreich, LE1 5WW
- Rekrutierung
- University Hospitals of Leicester
-
Hauptermittler:
- Matthew Lee
-
Kontakt:
- Site Contact
- E-Mail: matthew.lee3@nhs.net
-
-
Lincolnshire
-
Lincoln, Lincolnshire, Vereinigtes Königreich, LN2 5QY
- Rekrutierung
- Lincolnshire Community and Hospitals NHS group
-
Hauptermittler:
- Ciro Rinaldi
-
Kontakt:
- Site Contact
- E-Mail: crinaldi@nhs.net
-
-
Tyne and Wear
-
High Heaton, Tyne and Wear, Vereinigtes Königreich, NE7 7DN
- Rekrutierung
- The Newcastle Upon Tyne University Hospitals Foundation Trust
-
Kontakt:
- Site Contact
- E-Mail: michelle.lannon@nhs.net
-
Hauptermittler:
- Michelle Lannon
-
Sunderland, Tyne and Wear, Vereinigtes Königreich, SR4 7TP
- Noch keine Rekrutierung
- South Tyneside and Sunderland Foundation Trust
-
Hauptermittler:
- Scott Marshall
-
Kontakt:
- Site Contact
- E-Mail: scott.marshall3@nhs.net
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
-
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
-
Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
-
Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow sample, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. In cases where a local bone marrow (BM) assessment establishing an MDS diagnosis was conducted within 12 weeks prior to informed consent form (ICF) signature, the associated local BM samples and/or reports may be permitted.
-
Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
-
Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥30,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥3 doses or ≥ 120 μg every week for ≥ 8 doses or equivalent.
b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).
-
Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.
-
Eastern Cooperative Oncology Group performance status of 0 to 2.
-
Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
-
In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
Exclusion Criteria:
-
Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS).
-
Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
-
Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
-
Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
- Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening;
- Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.
-
Known ejection fraction <35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
-
Child-Pugh class C hepatic impairment.
-
Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
-
Any known history of acute myeloid leukemia (AML).
-
Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 2 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
-
History of solid organ or bone marrow transplantation.
-
Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
-
Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell count > 200 cells per microliter (cells/μL) at screening. Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
-
Body mass index ≥ 40 kilograms per meter square (kg/m^2).
-
Major surgery within 28 days before randomization.
-
History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
-
Prior use of elritercept, luspatercept, or sotatercept.
-
Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
-
Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥ 8 weeks are allowed.
-
Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
-
Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.
-
High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.
-
Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
-
Ongoing participation in another interventional clinical study.
-
Serum EPO level >500 U/L.
-
Platelet count ≥800 × 10^9 per liter (/L) or ≤25 × 10^9/L.
-
Absolute neutrophil count ≤ 500 per microliter (/µL).
-
Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
-
Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. Participants with known history of Gilbert syndrome with unconjugated bilirubin < 3 × ULN are allowed. Higher levels, if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis), may be allowed upon medical monitor review.
-
Ferritin ≤ 50 micrograms per litre (μg/L).
-
Folate ≤2.0 nanograms per milliliter (ng/mL).
-
Vitamin B12 ≤200 picograms per milliliter (pg/mL).
-
Estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
-
Pregnant or lactating female.
-
Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
-
Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or CRO directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
-
For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Elritercept
Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. |
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Andere Namen:
|
|
Placebo-Komparator: Placebo
Participants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. |
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Zeitfenster: Baseline through Week 24
|
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24. |
Baseline through Week 24
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Participants Achieving TI for ≥24 Weeks
Zeitfenster: Baseline through Week 48
|
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48. |
Baseline through Week 48
|
|
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
Zeitfenster: Baseline through Week 24
|
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24. |
Baseline through Week 24
|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Zeitfenster: From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
|
An adverse event (AE) is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not it is related to study treatment. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. |
From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
|
|
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
Zeitfenster: From the time of signing the informed consent form through safety follow-up, approximately 16 months
|
Change from baseline in clinical laboratory values, vital signs, and ECGs will be assessed. |
From the time of signing the informed consent form through safety follow-up, approximately 16 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Study Director, Takeda
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KER-050-D301
- 2024-516009-22-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD-Sharing-Zugriffskriterien
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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