En undersøgelse af mezagitamab hos voksne med kronisk primær immun trombocytopeni
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektivitet og sikkerhed af mezagitamab subkutan injektion hos deltagere med kronisk primær immun trombocytopeni
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Takeda Contact
- Telefonnummer: +1-877-825-3327
- E-mail: medinfoUS@takeda.com
Studiesteder
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Australien, 2605
- Rekruttering
- Canberra Hospital
-
Ledende efterforsker:
- Philip Choi
-
Kontakt:
- Site Contact
- Telefonnummer: +61251248492
- E-mail: phil.choi@act.gov.au
-
-
New South Wales
-
Concord, New South Wales, Australien, 2139
- Rekruttering
- Concord Repatriation General Hospital
-
Ledende efterforsker:
- Vivien Chen
-
Kontakt:
- Site Contact
- Telefonnummer: +610297676348
- E-mail: vivien.chen@health.nsw.gov.au
-
Kogarah, New South Wales, Australien, 2217
- Rekruttering
- St George Hospital
-
Ledende efterforsker:
- Silvia Zheng
-
Kontakt:
- Site Contact
- Telefonnummer: +610291131111
- E-mail: silvia.zheng@health.nsw.gov.au
-
Liverpool, New South Wales, Australien, 2170
- Rekruttering
- University of New South Wales (UNSW) - Liverpool Hospital - Liverpool Cancer Therapy Centre
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Danny Hsu
-
Westmead, New South Wales, Australien, 2145
- Rekruttering
- Westmead Hospital
-
Ledende efterforsker:
- Jennifer Curnow
-
Kontakt:
- Site Contact
- Telefonnummer: +610288905200
- E-mail: Jennifer.curnow@health.nsw.gov.au
-
-
Victoria
-
Melbourne, Victoria, Australien, 3000
- Rekruttering
- Peter MacCallum Cancer Centre
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Isaac Goncalves
-
Melbourne, Victoria, Australien, 3005
- Rekruttering
- The Alfred Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Huyen Tran
-
Melbourne, Victoria, Australien, 3004
- Rekruttering
- Monash University - Australian Centre for Blood Diseases (ACBD)
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Zane Kaplan
-
-
Western Australia
-
Murdoch, Western Australia, Australien, 6150
- Rekruttering
- Fiona Stanley Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Dominic Pepperell
-
West Perth, Western Australia, Australien, 6005
- Rekruttering
- Perth Blood Institute
-
Ledende efterforsker:
- Ross Baker
-
Kontakt:
- Site Contact
- Telefonnummer: +61892005300
- E-mail: ross@pbi.org.au
-
-
-
-
-
Plovdiv, Bulgarien, 4002
- Aktiv, ikke rekrutterende
- Medical Center "Fama Medical"
-
Sofia, Bulgarien, 1431
- Aktiv, ikke rekrutterende
- UMHAT Sv. Ivan Rilski
-
Sofia, Bulgarien, 1750
- Aktiv, ikke rekrutterende
- UMHAT SofiaMed, OOD
-
Stara Zagora, Bulgarien, 6003
- Aktiv, ikke rekrutterende
- University Multiprofile Hospital for Active Treatment - Prof. Dr. Stoyan Kirkovich AD
-
-
Sofia-Grad
-
Sofia, Sofia-Grad, Bulgarien, 1606
- Aktiv, ikke rekrutterende
- Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
-
-
-
-
-
London, Det Forenede Kongerige, NW1 2PG
- Aktiv, ikke rekrutterende
- University College London Hospitals
-
London, Det Forenede Kongerige, E11BB
- Aktiv, ikke rekrutterende
- Barts Health NHS Trust, Royal London Hospital
-
London, Det Forenede Kongerige, W12 0HS
- Aktiv, ikke rekrutterende
- Imperial College Healthcare NHS Trust
-
-
East Midlands
-
Leicester, East Midlands, Det Forenede Kongerige, LE1 5WW
- Aktiv, ikke rekrutterende
- University Hospitals of Leicester NHS Trust
-
-
Hampshire
-
Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
- Aktiv, ikke rekrutterende
- Southampton General Hospital
-
-
London
-
Southwark, London, Det Forenede Kongerige, SE1 9RT
- Aktiv, ikke rekrutterende
- Guy's Hospital - Guy's & St. Thomas NHS Foundation Trust
-
-
Merseyside
-
Liverpool, Merseyside, Det Forenede Kongerige, L7 8XP
- Aktiv, ikke rekrutterende
- Royal Liverpool and Broadgreen University Hospitals NHS Trust
-
-
Scotland
-
Glasgow, Scotland, Det Forenede Kongerige, G312ER
- Aktiv, ikke rekrutterende
- Greater Glasgow Health Board
-
-
Staffordshire
-
Stoke-on-Trent, Staffordshire, Det Forenede Kongerige, ST4 6QG
- Aktiv, ikke rekrutterende
- University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital
-
-
Yorkshire
-
Leeds, Yorkshire, Det Forenede Kongerige, LS9 TF
- Aktiv, ikke rekrutterende
- Leeds Teaching Hospitals NHS Trust
-
-
-
-
Arkansas
-
Hot Springs, Arkansas, Forenede Stater, 71913
- Rekruttering
- Genesis Cancer and Blood Institute - SCRI
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Lingyi Chen
-
-
California
-
Los Angeles, California, Forenede Stater, 90033
- Rekruttering
- USC Norris Comprehensive Cancer Center - Keck Medicine of USC
-
Ledende efterforsker:
- Howard Liebman
-
Kontakt:
- Site Contact
- E-mail: duran_c@med.usc.edu
-
San Diego, California, Forenede Stater, 92121
- Ikke rekrutterer endnu
- University of California San Diego Center for Bleeding and Clotting Disorders
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Annette Von Drygalski
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80218
- Trukket tilbage
- Rocky Mountain Cancer Center
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20007
- Rekruttering
- Georgetown University Medical Center - Lombardi Comprehensive Cancer Center
-
Ledende efterforsker:
- Catherine Broome
-
Kontakt:
- Site Contact
- Telefonnummer: 202-687-3044
- E-mail: js4936@georgetown.edu
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30308
- Rekruttering
- Emory University
-
Ledende efterforsker:
- Ana Antun
-
Kontakt:
- Site Contact
- Telefonnummer: 404-778-7062
- E-mail: ana.antun@emoryhealthcare.org
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46260
- Rekruttering
- Innovative Hematology, Inc.
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Sherwin Desouza
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- Rekruttering
- The University of Iowa
-
Ledende efterforsker:
- Steven Lentz
-
Kontakt:
- Site Contact
- Telefonnummer: 319-384-9643
- E-mail: darby-donovan@uiowa.edu
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40202
- Rekruttering
- University Of Louisville Brown Cancer Center
-
Ledende efterforsker:
- Kamila Cisak
-
Kontakt:
- Site Contact
- Telefonnummer: 502-562-3429
- E-mail: t0trox01@louisville.edu
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20817
- Rekruttering
- American Oncology Partners of Maryland, PA
-
Ledende efterforsker:
- Ralph Boccia
-
Kontakt:
- Site Contact
- Telefonnummer: 301-571-2016
- E-mail: Taylor.Stutzman@aoncology.com
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Ledende efterforsker:
- David Kuter
-
Kontakt:
- Site Contact
- Telefonnummer: 617-726-8743
- E-mail: dkuter@mgh.harvard.edu
-
Worcester, Massachusetts, Forenede Stater, 01655
- Afsluttet
- University of Massachusetts Chan Medical School
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64132
- Rekruttering
- MidAmerica Cancer Center
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Benjamin Fangman
-
-
New York
-
New York, New York, Forenede Stater, 28204
- Rekruttering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Avi Leader
-
The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Montefiore Medical Center
-
Ledende efterforsker:
- Irina Murakhovskaya
-
Kontakt:
- Site Contact
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Hospital
-
Ledende efterforsker:
- Ara Metjian
-
Kontakt:
- Site Contact
- Telefonnummer: 919-681-2668
- E-mail: Kristin.byrne@duke.edu
-
Greenville, North Carolina, Forenede Stater, 27837
- Rekruttering
- East Carolina University
-
Ledende efterforsker:
- Darla Liles
-
Kontakt:
- Site Contact
- Telefonnummer: 252-744-3617
- E-mail: Wootenk16@ecu.edu
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Ikke rekrutterer endnu
- Cleveland Clinic
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Bethany Samuelson Bannow
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Rekruttering
- Oregon Health & Science University
-
Ledende efterforsker:
- Joseph Shatzel
-
Kontakt:
- Site Contact
- Telefonnummer: 503-949-1080
- E-mail: trials@ohsu.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19140
- Rekruttering
- Lewis Katz School of Medicine at Temple University
-
Kontakt:
- Site Contact
- Telefonnummer: 215-707-3453
- E-mail: michael.bromberg@tuhs.temple.edu
-
Ledende efterforsker:
- Michael Bromberg
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Perelman Center for Advanced Medicine (PCAM) Hospital of The University of Pennsylvania Penn Blood Disorders Program
-
Ledende efterforsker:
- Adam Cuker
-
Kontakt:
- Site Contact
- Telefonnummer: 862-372-8544
- E-mail: emmanuel.ndukwudimma@pennmedicine.upenn.edu
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Baylor College of Medicine
-
Ledende efterforsker:
- Senthil Sukumar
-
Kontakt:
- Site Contact
- E-mail: senthil.sukumar@bcm.edu
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Oncology Associates
-
Ledende efterforsker:
- Celeste Bremer
-
Kontakt:
- Site Contact
- Telefonnummer: 404-778-7062
- E-mail: ana.antun@emoryhealthcare.org
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Ikke rekrutterer endnu
- University of Washingto
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Sandhya Panch
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Versiti Wisconsin, Inc
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Lisa Kreuziger
-
-
-
-
-
Créteil, Frankrig, 94000
- Ikke rekrutterer endnu
- Hospital Henri Mondor
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Marc Michel
-
-
Bourgogne-Franche-Comté
-
Dijon, Bourgogne-Franche-Comté, Frankrig, 1000
- Ikke rekrutterer endnu
- Chu Dijon - Bourgogne
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Bernard Bonnotte
-
-
-
-
-
Pátrai, Grækenland, 264 43
- Aktiv, ikke rekrutterende
- Olympion General Clinic & Rehabilitation Center
-
Thessaloniki, Grækenland, 570 10
- Aktiv, ikke rekrutterende
- General Hospital of Thessaloniki George Papanikolaou
-
-
-
-
South Holland
-
Rotterdam, South Holland, Holland, 3015 GD
- Aktiv, ikke rekrutterende
- Erasmus Medical Center, Department of Hematology
-
The Hague, South Holland, Holland, 2545AA
- Aktiv, ikke rekrutterende
- Hagaziekenhuis
-
-
-
-
Pok Fu Lam
-
Hong Kong, Pok Fu Lam, Hong Kong
- Rekruttering
- Queen Mary Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Yok Lam Kwong
-
-
-
-
-
Bologna, Italien, 40123
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
-
Milan, Italien, 20162
- Ikke rekrutterer endnu
- ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Monica Carpenedo
-
Monza, Italien, 20900
- Aktiv, ikke rekrutterende
- Fondazione IRCCS San Gerardo Dei Tintori
-
Novara, Italien, 28100
- Aktiv, ikke rekrutterende
- A.O.U. Maggiore della Carita
-
Rome, Italien, oo133
- Ikke rekrutterer endnu
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Francesco Buccisano
-
Torino, Italien, 10126
- Aktiv, ikke rekrutterende
- AOU Citta della Salute e della Scienza di Torino
-
Trieste, Italien, 34129
- Aktiv, ikke rekrutterende
- Azienda sanitaria universitaria Giuliano Isontina
-
Vicenza, Italien, 36100
- Aktiv, ikke rekrutterende
- Azienda ULSS 8 Berica - Ospedale San Bortolo
-
-
Campania
-
Naples, Campania, Italien, 80131
- Ikke rekrutterer endnu
- Azienda Ospedaliera Universitaria Federico II
-
Ledende efterforsker:
- Fabrizio Pane
-
Kontakt:
- Site Contact
- Telefonnummer: +39 081 7464289
- E-mail: fabrizio.pane@unina.it
-
-
Lazio
-
Rome, Lazio, Italien, oo610
- Aktiv, ikke rekrutterende
- Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma
-
-
Sicily
-
Catania, Sicily, Italien, 95122
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
-
-
-
-
Chiba
-
Chuo-ku, Chiba, Japan, 260-0852
- Rekruttering
- Chiba Aoba Municipal Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Yokota Akira
-
Narashino-shi, Chiba, Japan, 275-8580
- Rekruttering
- Chibaken Saiseikai Narashino Hospital
-
Ledende efterforsker:
- Ryuko Cho
-
Kontakt:
- Site Contact
- Telefonnummer: 047-473-1281
- E-mail: choryuko@gmail.com
-
-
Higashiibaraki
-
Ibaraki, Higashiibaraki, Japan, 311-3193
- Rekruttering
- National Hospital Organization Mito Medical Center
-
Ledende efterforsker:
- Chikashi Yoshida
-
Kontakt:
- Site Contact
- Telefonnummer: 029-240-7711
- E-mail: Yoshida.chikashi.rc@mail.hosp.go.jp
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 232-0024
- Rekruttering
- Yokohama City University Medical Center
-
Ledende efterforsker:
- Takuya Miyazaki
-
Kontakt:
- Site Contact
- Telefonnummer: 045-261-5656
- E-mail: takuya_m@yokohama-cu.ac.jp
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8574
- Rekruttering
- Tohoku University Hospital
-
Ledende efterforsker:
- Noriko Fukuhara
-
Kontakt:
- Site Contact
-
-
Osaka
-
Hirakata-shi, Osaka, Japan, 573-1191
- Rekruttering
- Kansai Medical University Hospital
-
Ledende efterforsker:
- Tomoki Ito
-
Kontakt:
- Site Contact
- E-mail: tot@hirakata.kmu.ac.jp
-
Osaka, Osaka, Japan, 542-0081
- Rekruttering
- Hematology Ohta Clinic,Shinsaibashi
-
Ledende efterforsker:
- Kensuke Ohta
-
Kontakt:
- Site Contact
- Telefonnummer: 81 6-6245-2117
-
Suita-shi, Osaka, Japan, 565-0871
- Rekruttering
- Osaka University Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Kato Hisashi
-
-
Saitama
-
Iruma-gun, Saitama, Japan, 350-0495
- Rekruttering
- Saitama Medical University Hospital
-
Ledende efterforsker:
- Yoshitaka Miyakawa
-
Kontakt:
- Site Contact
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8655
- Rekruttering
- The University of Tokyo Hospital
-
Ledende efterforsker:
- Mineo Kurokawa
-
Kontakt:
- Site Contact
- Telefonnummer: 03-3815-5411
- E-mail: kurokawa@m.u-tokyo.ac.jp
-
Sumida-ku, Tokyo, Japan, 130-0022
- Rekruttering
- Tokyo Metropolitan Bokutoh Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Kosugi Nobuharu
-
tabashi City, Tokyo, Japan, 173-8610
- Rekruttering
- Nihon University Itabashi Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 03-3972-8111
- E-mail: ootake.shimon@nihon-u.ac.jp
-
Ledende efterforsker:
- Otake Shimon
-
-
Yamanashi
-
Kofu, Yamanashi, Japan, 400-8506
- Rekruttering
- Yamanashi Prefectural Central Hospital
-
Ledende efterforsker:
- Masaki Iino
-
Kontakt:
- Site Contact
- Telefonnummer: 055-253-7111
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
-
Ledende efterforsker:
- Tienan Zhu
-
Kontakt:
- Site Contact
- Telefonnummer: +861069155027
- E-mail: zhutn@pumch.cn
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- Afsluttet
- Guangdong Provincial People's Hospital
-
-
Guangxi
-
Nanning, Guangxi, Kina, 530021
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
-
Ledende efterforsker:
- Peng Cheng
-
Kontakt:
- Site Contact
- Telefonnummer: +867715356566
- E-mail: jhlee3@amc.seoul.kr
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050031
- Rekruttering
- The First Hospital of Hebei Medical University
-
Ledende efterforsker:
- Qingchi Liu
-
Kontakt:
- Site Contact
- Telefonnummer: +8631185917000
- E-mail: liuqingchi@sina.com
-
Wuhan, Hebei, Kina, 430022
- Rekruttering
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Ledende efterforsker:
- Yu Hu
-
Kontakt:
- Site Contact
- Telefonnummer: +8613986183871
- E-mail: dr_huyu@126.com
-
-
Henan
-
Zhengzhou, Henan, Kina, 450004
- Rekruttering
- Henan Cancer Hospital
-
Ledende efterforsker:
- Hu Zhou
-
Kontakt:
- Site Contact
- Telefonnummer: +8637165587320
- E-mail: tigerzhoupumc@163.com
-
-
Jiangsu
-
Suzhou, Jiangsu, Kina, 215006
- Rekruttering
- The First Affiliated Hospital of Soochow University - Shizijie Campus
-
Ledende efterforsker:
- Jie Yin
-
Kontakt:
- Site Contact
- Telefonnummer: +8613651003886
- E-mail: yinjie@suda.edu.cn
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- Rekruttering
- The First Affiliated Hospital of Nanchang University - Donghu Campus
-
Ledende efterforsker:
- Ruibin Huang
-
Kontakt:
- Site Contact
- Telefonnummer: +867918692517
- E-mail: rbhuang69@163.com
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110004
- Rekruttering
- Shengjing Hospital of China Medical University - Nanhu Campus
-
Ledende efterforsker:
- Aijun Liao
-
Kontakt:
- Site Contact
- Telefonnummer: +8618940259833
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710068
- Afsluttet
- Shaanxi Provincial People's Hospital
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
-
Ledende efterforsker:
- Ming Hou
-
Kontakt:
- Site Contact
- Telefonnummer: +8653182169114-9879
- E-mail: houming@medmail.com.cn
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 201508
- Rekruttering
- Jinshan Hospital of Fudan University
-
Ledende efterforsker:
- Yunfeng Cheng
-
Kontakt:
- Site Contact
- Telefonnummer: +862164041990Ext.2718
- E-mail: ypark@augusta.edu
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610041
- Rekruttering
- West China Hospital Sichuan University
-
Ledende efterforsker:
- Yuping Gong
-
Kontakt:
- Site Contact
- Telefonnummer: +862885422366
- E-mail: huaxigcp@163.com
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300020
- Rekruttering
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
-
Ledende efterforsker:
- Yunfei Chen
-
Kontakt:
- Site Contact
- Telefonnummer: +8613502157159
- E-mail: chenyunfei@ihcams.ac.cn
-
-
Yunnan
-
Kunming, Yunnan, Kina, 650101
- Rekruttering
- The Second Affiliated Hospital of Kunming Medical University
-
Ledende efterforsker:
- Zeping Zhou
-
Kontakt:
- Site Contact
- Telefonnummer: +8618788571605
- E-mail: zhouzeping@kmmu.edu.cn
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310006
- Afsluttet
- Zhejiang Provincial Hospital of Chinese Medicine - Main
-
-
-
-
-
Zagreb, Kroatien, 10000
- Ikke rekrutterer endnu
- Clinical Hospital Centar Zagreb
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Drazen Pulanic
-
-
-
-
-
Bergen, Norge, 5021
- Rekruttering
- Universitetet i Bergen
-
Ledende efterforsker:
- Galina Tsykunova
-
Kontakt:
- Site Contact
- Telefonnummer: 47 55-97-50-00
- E-mail: galina.tsykunova@helse-bergen.no
-
Grålum, Norge, 1714
- Aktiv, ikke rekrutterende
- Sykehuset Ostfold
-
Lorenskog, Norge, 1478
- Aktiv, ikke rekrutterende
- Akershus Universitetssykehus
-
-
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-048
- Trukket tilbage
- IN-VIVO sp. z o.o.
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 02-776
- Aktiv, ikke rekrutterende
- Instytut Hematologii i Transfuzjologii Klinika Zaburzen Hemostazy i Chorob Wewnetrznych
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Polen, 40-523
- Aktiv, ikke rekrutterende
- Pratia Onkologia Katowice - PRATIA
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 93-513
- Aktiv, ikke rekrutterende
- N. Copernicus Provincial MCOT in Lodz
-
-
-
-
-
Madrid, Spanien, 28007
- Aktiv, ikke rekrutterende
- Hospital General Universitario Gregorio Maranon
-
Salamanca, Spanien, 37007
- Aktiv, ikke rekrutterende
- Hospital Universitario De Salaman
-
Seville, Spanien, 41013
- Aktiv, ikke rekrutterende
- Hospital Universitario Virgen del Rocio
-
-
Mardrid
-
Alcorcón, Mardrid, Spanien, 28922
- Aktiv, ikke rekrutterende
- Hospital Universitario Fundacion Alcorcon
-
Madrid, Mardrid, Spanien, 28041
- Aktiv, ikke rekrutterende
- Hospital Universitario 12 de Octubre
-
-
-
-
-
Malmö, Sverige, 205 02
- Ikke rekrutterer endnu
- Skanes University hospital, Hematology Department
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Alexandros Arvanitakis
-
-
Stockholm County
-
Huddinge, Stockholm County, Sverige, 14186
- Aktiv, ikke rekrutterende
- Karolinska Universitetssjukhuset
-
-
-
-
-
Daegu, Sydkorea, 41944
- Rekruttering
- Kyungpook National University Hospital
-
Ledende efterforsker:
- Sang-Kyun Sohn
-
Kontakt:
- Site Contact
-
Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- June-Won Cheong
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Jun Ho Jang
-
Seoul, Sydkorea, 5505
- Rekruttering
- Asan Medical Center
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Je-Hwan Lee
-
Seoul, Sydkorea, 2841
- Rekruttering
- Korea University Anam Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Yong Park
-
Seoul, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital (SNUH)
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Youngil Koh
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
Kontakt:
- Site Contact
-
Ledende efterforsker:
- Soo-Mee Bang
-
-
-
-
-
Edirne, Tyrkiet (Türkiye), 22030
- Rekruttering
- Cerrahpasa Tip Fakultesi
-
Kontakt:
- Site Contact
- Telefonnummer: 905326818890
- E-mail: mcemar68@yahoo.com
-
Ledende efterforsker:
- Muhlis Cem Ar
-
Edirne, Tyrkiet (Türkiye), 22030
- Rekruttering
- Trakya Universitesi Tip Fakultesi Hastanesi
-
Kontakt:
- Site Contact
- Telefonnummer: 905336000000
- E-mail: mdemir@trakya.edu.tr
-
Ledende efterforsker:
- Ahmet Muzaffer Demir
-
Sakarya, Tyrkiet (Türkiye), 54290
- Ikke rekrutterer endnu
- Sakarya University Education and Research Hospital
-
Ledende efterforsker:
- Tuba Hacibekiroglu
-
Kontakt:
- Site Contact
- Telefonnummer: 905054785579
- E-mail: hacibekiroglu@sakarya.edu.tr
-
-
Ankara
-
Mamak, Ankara, Tyrkiet (Türkiye), 6620
- Rekruttering
- Ankara University Faculty of Medicine Cebeci Hospital, Department of Hematology
-
Ledende efterforsker:
- Selami Toprak
-
Kontakt:
- Site Contact
- Telefonnummer: 905327000000
- E-mail: sktoprak@yahoo.com
-
-
Aydın
-
Efeler, Aydın, Tyrkiet (Türkiye), 9100
- Rekruttering
- Aydin Adnan Menderes University Medical Faculty-Hematology Department
-
Ledende efterforsker:
- Irfan Yavasoglu
-
Kontakt:
- Site Contact
- E-mail: dryavas09@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
- The participant has been diagnosed with ITP that has persisted for at least 12 months.
- The participant's diagnosis of ITP is supported by a prior response to an ITP therapy (not including a thrombopoietin receptor agonist [TPO-RA]), defined as having achieved a platelet count ≥50,000/μL.
- The participant has evidence of insufficient response or intolerance to at least 1 currently available first-line therapy for treatment of ITP (for example, corticosteroids), and at least 1 currently available second-line therapy for treatment of ITP (for example, TPO-RA, rituximab, fostamatinib, mycophenolate). Insufficient response to previous treatment is defined as failure to achieve a sustained platelet count of at least 50,000/μL or doubling of baseline platelet count after an appropriate course of prior ITP treatment. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
- The participant has a mean platelet count of less than (<)30,000/μL.
- If the participant is receiving allowed standard-of-care treatment for ITP at screening, and continued use is intended, treatment may continue during the trial if the dose, and frequency have been stable for at least 4 weeks before receiving the first dose of IMP (i.e., Day 1), and are expected to remain stable throughout the trial.
- If the participant is an individual with potential for pregnancy, the participant is not pregnant as confirmed by negative human chorionic gonadotropin during screening, and before the first dose of trial intervention.
Key Exclusion Criteria:
-
The participant has secondary ITP.
-
The participant has had any thrombotic or embolic event within 12 months before signing the informed consent form (ICF).
-
The participant has had a splenectomy.
-
The participant has active infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
-
History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for treated non-melanoma skin cancer or cervical carcinoma in situ.
-
In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
-
The participant has received anti-cluster of differentiation (CD) 20 treatment within 12 months before screening, and either of the following applies:
- The last dose was received within 6 months before screening.
- The last dose was received between 6 and 12 months before screening, and the participant has a cluster of differentiation 19 positive (CD19+) count below the lower limit of normal.
-
The participant has received any monoclonal or polyclonal antibody for immunomodulation within 6 months before screening.
-
The participant has any prior exposure to mezagitamab or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Day 1.
-
The participant has used anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) within 3 weeks prior to the first dose of trial treatment.
-
The participant has received a live or live-attenuated vaccine within 4 weeks prior to the first dose of trial treatment or has any live or live-attenuated vaccine planned during the trial.
-
The participant has used the following immunosuppressive agents as specified prior to the first dose of trial treatment: alkylating agents (e.g., cyclophosphamide) within 8 weeks, vinca alkaloids (e.g., vincristine) within 4 weeks, sulfones (e.g., dapsone) within 3 weeks, antiproliferative agents: (e.g., mycophenolate mofetil, and azathioprine) within 2 weeks, and calcineurin inhibitors: (e.g., cyclosporine) within 2 weeks.
-
The participant has used intravenous immunoglobulin (IVIg), SC immunoglobulin, recombinant human thrombopoietin, anti-D immunoglobulin treatment, or efgartigimod within 4 weeks before signing the ICF or it is expected that any treatment for thrombocytopenia other than the participant's standard-of-care ITP therapy (e.g., rescue therapy, administration of blood products) may be used between screening, and Day 1.
-
The participant has a history of severe allergic or anaphylactic reactions to recombinant proteins or excipients used in the mezagitamab/placebo formulation.
Other protocol defined inclusion/exclusion criteria may apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mezagitamab
Participants will receive mezagitamab injection, SC, once weekly (QW). They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses. |
Mezagitamab injection administered SC.
Andre navne:
|
|
Placebo komparator: Placebo
Participants will receive mezagitamab-matching placebo injection, SC, QW. They will receive 8 weekly doses, followed by 8 weekly doses off, and then receive 8 more weekly doses. |
Mezagitamab-matching placebo injection administered SC. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Durable Platelet Response
Tidsramme: Up to Week 24
|
Durable platelet response is defined as platelet count greater than or equal to (≥)50,000/microliter (μL) on at least 4 of the 6 weekly platelet measurements between Weeks 19 and 24. |
Up to Week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tid til første blodpladetal ≥50.000/μL
Tidsramme: Op til uge 24
|
Op til uge 24
|
|
|
Procentdel af deltagere, der modtager redningsterapi
Tidsramme: Op til uge 24
|
Op til uge 24
|
|
|
Ændring i ADA-titre over tid
Tidsramme: Op til dag 169
|
Op til dag 169
|
|
|
Serumkoncentration af mezagitamab under og efter intervention
Tidsramme: Predose på dag 1 og på flere tidspunkter efter dosis op til dag 169
|
Predose på dag 1 og på flere tidspunkter efter dosis op til dag 169
|
|
|
Number of Participants With Anti-drug Antibodies (ADA)
Tidsramme: Predose on Day 1 and at multiple time points post-dose up to Day 169
|
Predose on Day 1 and at multiple time points post-dose up to Day 169
|
|
|
Number of Participants With Neutralizing ADA
Tidsramme: Predose on Day 1 and at multiple time points post-dose up to Day 169
|
Predose on Day 1 and at multiple time points post-dose up to Day 169
|
|
|
Cumulative Number of Weeks With a Platelet Count of ≥50,000/μL
Tidsramme: Up to Week 24
|
The cumulative number of weeks in which the platelet count is ≥50,000/μL through Week 24. |
Up to Week 24
|
|
Cumulative Number of Weeks With a Platelet Count of ≥30,000/μL
Tidsramme: Up to Week 24
|
The cumulative number of weeks in which the platelet count is ≥30,000/μL, and at least doubled from baseline through Week 24. |
Up to Week 24
|
|
Percentage of Participants With Complete Platelet Response
Tidsramme: Up to Week 24
|
Complete platelet response is defined as a platelet count ≥100,000/μL on at least 2 visits through Week 24. |
Up to Week 24
|
|
Percentage of Participants With Platelet Response at Week 16
Tidsramme: Week 16
|
Platelet response is defined as a platelet count ≥50,000/μL before investigational medicinal product (IMP) administration at the Week 16 visit. |
Week 16
|
|
Change from Baseline in the Symptoms Domain Score of the Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) at Weeks 16 and 24
Tidsramme: Weeks 16 and 24
|
ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. The 6-item symptoms domain is scored from 0 to 100, with a positive change from baseline representing improvement of symptoms. |
Weeks 16 and 24
|
|
Change from Baseline in Physical Fatigue (Item 10) Score of the ITP-PAQ at Weeks 16 and 24
Tidsramme: Weeks 16 and 24
|
ITP-PAQ is a 44-item participant reported outcome (PRO) measure that assesses disease-specific health-related quality of life (HRQoL) that includes 10 domains: Symptoms, Fatigue/Sleep, Physical Health - Bother, Physical Health - Activity, Emotional Health - Psychological, Emotional Health - Fear, Overall Quality of Life (QoL), Social Activity, Women's Reproductive Health (including Fertility subscale, and Menstrual Symptoms subscale), and Work. Physical fatigue is scored from 0 to 100, with a positive change from baseline representing improvement in physical fatigue. |
Weeks 16 and 24
|
|
Percentage of Participants With Bleeding Events
Tidsramme: Up to Week 24
|
Bleeding events are defined as Grade ≥2 in the skin domain, or Grade ≥1 in the mucosal domain, or Grade ≥1 in the organ domain, in the immune thrombocytopenia-specific bleeding assessment tool (ITP-BAT) through Week 24. |
Up to Week 24
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Study Director, Takeda
Publikationer og nyttige links
Generelle publikationer
Hjælpsomme links
- <p>Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.</p>
- <p>Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.</p>
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Blodkoagulationsforstyrrelser
- Trombotiske mikroangiopatier
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Cytopeni
- Trombocytopeni
- Purpura
- Purpura, trombocytopenisk, idiopatisk
- Purpura, trombocytopenisk
- Autoimmune sygdomme
- Hæmatologiske sygdomme
- Blødning
- Sygdomme i immunsystemet
- Blodpladeforstyrrelser
- Hæmoragiske lidelser
- Hudmanifestationer
Andre undersøgelses-id-numre
- TAK-079-3002
- 2024-514401-54-00 (Ctis)
- jRCT2031240667 (Registry Identifier: jRCT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .