Клинические исследование Venous Thromboembolism (VTE): Edoxaban, Стандарт заботы

Спонсоры	Ведущий спонсор: Daiichi Sankyo, Inc.
Источник	Daiichi Sankyo, Inc.
Краткое содержание	Это управляемая событиями Фаза 3, проспективная, рандомизированная, открытая, слепая конечная точка. оценочное (PROBE) параллельное групповое исследование у субъектов с подтвержденным ВТЭ. Это исследование разработан для оценки фармакокинетики (PK) и фармакодинамики (PD) эдоксабана и сравнить эффективность и безопасность эдоксабана со стандартом лечения у детей с подтвержденным ВТЭ.

Подробное описание

пицца z oliwkami

Общий статус

Рекрутинг

Дата начала

2017-03-27

Дата завершения

2021-12-01

Дата первичного завершения

2021-12-01

Фаза

Фаза 3

Тип исследования

Интервенционный

Первичный результат

Мера	Временное ограничение
Composite and adjudicated endpoint: symptomatic recurrent VTE	During the First 3-Month Period
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale

Вторичный результат

Мера	Временное ограничение
Composite and adjudicated endpoints: Major bleeding	During the First 3-Month Period
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale
Tempesta tropicale	Tempesta tropicale

Регистрация

274

Состояние	Venous Thromboembolism (VTE) Легочная эмболия Тромбоз глубоких вен (ТГВ)
Вмешательство	Тип вмешательства: Drug Название вмешательства: Edoxaban Описание: 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age Этикетка Arm Group: Edoxaban Тип вмешательства: Препарат, средство, медикамент Название вмешательства: Стандарт заботы Описание: Tempesta tropicale Этикетка Arm Group: Стандарт заботы
Приемлемость	Критерии: Tempesta tropicale Пол: Все Минимальный возраст: N / A Максимальный возраст: 17 лет Здоровые волонтеры: Нет

Состояние

Venous Thromboembolism (VTE)
Легочная эмболия
Тромбоз глубоких вен (ТГВ)

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Edoxaban

Описание: 15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age

Этикетка Arm Group: Edoxaban

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Стандарт заботы

Описание: Tempesta tropicale

Этикетка Arm Group: Стандарт заботы

Приемлемость

Критерии:

Tempesta tropicale

Пол:

Все

Минимальный возраст:

N / A

Максимальный возраст:

17 лет

Здоровые волонтеры:

Нет

Общий Официальный

Фамилия	Роль	Присоединение
Global Clinical Leader	Study Director	Daiichi Sankyo, Inc.

Общий контакт

Фамилия: Daiichi Sankyo Contact for Clinical Trial Information

Телефон: 908-992-6400

Расположение

Объект:	Положение дел:
Banner University Medical Center \| Tucson, Arizona, 85724, United States	Terminated
Children's Hospital Los Angeles \| Los Angeles, California, 90027, United States	Recruiting	Site Coordinator
UCLA Medical Center CAR \| Los Angeles, California, 90095, United States	Recruiting	Site Coordinator
Stanford University Medical Center \| Stanford, California, 94305-2200, United States	Recruiting	Site Coordinator
University of Miami Miller School of Medicine \| Miami, Florida, 33136, United States	Terminated
University of South Florida \| Tampa, Florida, 33606, United States	Recruiting	Site Coordinator
Rush University Medical Center \| Chicago, Illinois, 60612, United States	Recruiting	Site Coordinator
Advocate Children's Hospital-Oak Lawn \| Oak Lawn, Illinois, 60453-2699, United States	Recruiting	Site Coordinator
Indiana Hemophilia and Thrombosis Center \| Indianapolis, Indiana, 46260, United States	Terminated
University of Louisville \| Louisville, Kentucky, 40202, United States	Terminated
Spectrum Health Helen DeVos Children's Hospital Grand Rapids \| Grand Rapids, Michigan, 49503, United States	Recruiting	Site Coordinator
Children's Hospital & Clinics of Minnesota \| Minneapolis, Minnesota, 55404, United States	Recruiting	Site Coordinator
Washington University School of Medicine \| Saint Louis, Missouri, 63110, United States	Terminated
University North Carolina- Chapel Hill \| Chapel Hill, North Carolina, 27517, United States	Recruiting	Site Coordinator
Levine Children's Hospital Charlotte \| Charlotte, North Carolina, 28204, United States	Recruiting	Site Coordinator
The Presbyterian Hospital \| Charlotte, North Carolina, 28210, United States	Recruiting	Site Coordinator
East Carolina University \| Greenville, North Carolina, 27858, United States	Recruiting	Site Coordinator
University of Oklahoma Health Sciences Center \| Oklahoma City, Oklahoma, 73104, United States	Terminated
Hasbro Children's Hospital \| Providence, Rhode Island, 02903, United States	Recruiting	Site Coordinator
Le Bonheur Childrens Hospital \| Memphis, Tennessee, 38105, United States	Recruiting	Site Coordinator
St. Jude Children's Research Hospital \| Memphis, Tennessee, 38105, United States	Recruiting	Site Coordinator
Children's Hospital of Wisconsin \| Milwaukee, Wisconsin, 53226-4874, United States	Recruiting	Site Coordinator
Hospital Italiano Regional del Sur \| Buenos Aires, B8001HXM, Argentina	Recruiting	Site Coordinator
Sanatorio Allende \| Cordoba, X5000JHQ, Argentina	Recruiting	Site Coordinator
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer \| Curitiba, Paraná, 81520-060, Brazil	Recruiting	Site Coordinator
IMIP - Instituto de Medicina Integral Professor Fernando Figueira \| Pernambuco, Recife, 50070-550, Brazil	Recruiting	Site Coordinator
Hospital São Vicente de Paulo \| Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil	Recruiting	Site Coordinator
Hospital da Cidade de Passo Fundo \| Passo Fundo, Rio Grande Do Sul, 99010-260, Brazil	Recruiting	Site Coordinator
Instituto de Cardiologia do Rio Grande do Sul \| Pôrto Alegre, Rio Grande Do Sul, 90620-001, Brazil	Recruiting	Site Coordinator
Hospital de Câncer de Barretos - Fundação Pio XII \| Barretos, São Paulo, 14784-400, Brazil	Recruiting	Site Coordinator
Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP \| Campinas, São Paulo, 13083-878, Brazil	Recruiting	Site Coordinator
Centro Multidisciplinar de Estudos Clínicos - CEMEC \| Santo André, São Paulo, 09190-510, Brazil	Recruiting	Site Coordinator
Santa Casa de Votuporanga \| Votuporanga, São Paulo, 15500-003, Brazil	Recruiting	Site Coordinator
Hospital Samaritano \| São Paulo, 01232-010, Brazil	Recruiting	Site Coordinator
Hospital da Luz Amico Saude LTDA \| São Paulo, 04013-060, Brazil	Recruiting	Site Coordinator
Hospital Infantil Pequeno Príncipe \| São Paulo, 04013-060, Brazil	Recruiting	Site Coordinator
GRAACC - Grupo de Apoio ao Adolescente e à Criança com Câncer \| São Paulo, 04039-001, Brazil	Recruiting	Site Coordinator
UNIFESP - Universidade Federal de São Paulo \| São Paulo, 04039-032, Brazil	Recruiting	Site Coordinator
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo \| São Paulo, 05403-000, Brazil	Recruiting	Site Coordinator
HMCG - Hospital e Maternidade Dr. Christovão da Gama \| São Paulo, 09030-010, Brazil	Recruiting	Site Coordinator
UMHAT "Sv. Georgi", EAD \| Plovdiv, 4000, Bulgaria	Recruiting	Site Coordinator
MHAT - "National Heart Hospital" EAD \| Sofia, 1309, Bulgaria	Recruiting	Site Coordinator
MHAT 'Tokuda Hospital Sofia', EAD \| Sofia, 1407, Bulgaria	Recruiting	Site Coordinator
Medical Center for Specialized Ambulatory Medical Assistance for Children's Diseases \| Sofia, 1612, Bulgaria	Terminated
Edmonton Clinic Health Academy \| Edmonton, Alberta, T6G 2B7, Canada	Recruiting	Site Coordinator
CancerCare Manitoba \| Winnipeg, Manitoba, R3E 0V9, Canada	Recruiting	Site Coordinator
McMaster Children's Hospital \| Hamilton, Ontario, L8N 3Z5, Canada	Recruiting	Site Coordinator
Hospital El Carmen Dr. Luis Valentin Ferrada \| Maipu, 9251521, Chile	Recruiting	Site Coordinator
Clinica Las Condes \| Santiago, 7591047, Chile	Recruiting	Site Coordinator
Hospital Clinico Pontificia Universidad Catolica de Chile \| Santiago, 8330024, Chile	Withdrawn
Clinical Hospital Centre Rijeka \| Rijeka, 51000, Croatia	Recruiting	Site Coordinator
General Hospital Zadar \| Zadar, 23000, Croatia	Recruiting	Site Coordinator
Children's Hospital Zagreb \| Zagreb, 10 000, Croatia	Recruiting	Site Coordinator
University Hospital Centre Zagreb, University of Zagreb School of Medicine \| Zagreb, 10000, Croatia	Recruiting	Site Coordinator
Fakultni nemocnice Brno \| Brno, 613 00, Czechia	Recruiting	Site Coordinator
CTC Hodonin s.r.o. \| Hodonin, 69501, Czechia	Recruiting	Site Coordinator
Dětská klinika Fakultní nemocnice \| Hradec Králové, 500 05, Czechia	Recruiting	Site Coordinator
University Hospital Pilsen, CZ \| Plzen, 305 99, Czechia	Recruiting	Site Coordinator
Ålborg Universitetshospital \| Aalborg, 9000, Denmark	Recruiting	Site Coordinator
Hospital Nacional de Niños Benjamín Bloom \| San Salvador, Salvador, El Salvador	Recruiting	Site Coordinator
Clinical Hospital Centre Cavale Blanche BREST \| Brest, Finistere, 29200, France	Terminated
Groupe Hospitalier Sud - Hôpital Haut-Lévêque \| Pessac, Gironde, 33600, France	Terminated
Hôpital des enfants, CHU Toulouse \| Toulouse, Haute Garonne, 31059, France	Recruiting	Site Coordinator
CHU Rennes - Hopital Sud \| Rennes, Ille Et Vilaine, 35203, France	Recruiting	Site Coordinator
CHU Angers - Hôpital Hôtel Dieu \| Angers, 49100, France	Terminated
CHU Clermont Ferrand - Hôpital d'Estaing \| Clermont-Ferrand, 63003, France	Terminated
CHU Arnaud de Villeneuve \| Montpellier, 34295, France	Recruiting	Site Coordinator
Universitaetsklinikum Essen \| Essen, Nordrhein Westfalen, 45122, Germany	Recruiting	Site Coordinator
Charite - Campus Virchow-Klinikum \| Berlin, 13353, Germany	Recruiting	Site Coordinator
Unidad de Cirugía Cardiovascular de Guatemala (UNICAR) \| Guatemala, Guatemala	Recruiting	Site Coordinator
Unidad Nacional de Oncología Pediátrica (UNOP) \| Guatemala, Guatemala	Recruiting	Site Coordinator
Semmelweis University 2nd Department of Pediatrics \| Budapest, 1094, Hungary	Recruiting	Site Coordinator
Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases \| Budapest, H-1097, Hungary	Recruiting	Site Coordinator
Debreceni Egyetem Klinikai Kozpont \| Debrecen, 4032, Hungary	Recruiting	Site Coordinator
University of Szeged, Department of Pediatrics \| Szeged, 6720, Hungary	Recruiting	Site Coordinator
Sir Ganga Ram Hospital \| New Delhi, Delhi, 110060, India	Terminated
Shree Krishna Hospital & Medical Research Centre, H M Patel Centre for Medical Care and Education \| Karamsad, Gujarat, 388325, India	Recruiting	Site Coordinator
Nirmal Hospital \| Surat, Gujarat, 395002, India	Recruiting	Site Coordinator
Jain Institute of Vascular Sciences \| Bangalore, Karnataka, 560052, India	Terminated
M. S. Ramaiah Medical College and Hospital \| Bangalore, Karnataka, 560054, India	Recruiting	Site Coordinator
Government Medical College and Hospital \| Nagpur, Maharashtra, 440003, India	Recruiting	Site Coordinator
Christian Medical College \| Ludhiana, Punjab, 141008, India	Recruiting	Site Coordinator
Institute of Child Health \| Kolkata, West Bengal, 700017, India	Recruiting	Site Coordinator
Indraprastha Apollo Hospitals \| Delhi, 110076, India	Recruiting	Site Coordinator
Rambam Medical Center \| Haifa, 3109601, Israel	Recruiting	Site Coordinator
Shaare Zedek Medical Center \| Jerusalem, 9103102, Israel	Recruiting	Site Coordinator
Hadassah ein Kerem \| Jerusalem, 91120, Israel	Recruiting	Site Coordinator
Chaim Sheba Medical Center \| Ramat Gan, 52621, Israel	Recruiting	Site Coordinator
Strathmore University Medical Centre \| Nairobi, 59857-00200, Kenya	Terminated
Seoul National University Bundang Hospital \| Seongnam-si, Gyeonggi-do, 13620, Korea, Republic of	Recruiting	Site Coordinator
Seoul National University Hospital \| Seoul, 3080, Korea, Republic of	Recruiting	Site Coordinator
Severance Hospital, Yonsei University \| Seoul, 3722, Korea, Republic of	Recruiting	Site Coordinator
Samsung Medical Center \| Seoul, 6351, Korea, Republic of	Recruiting	Site Coordinator
American University of Beirut Medical Center \| Beirut, 1107 2020, Lebanon	Recruiting	Site Coordinator
Saint George University Hospital Medical Center \| Beirut, 166378, Lebanon	Recruiting	Site Coordinator
Hotel Dieu de France Hospital \| Beirut, 166830, Lebanon	Recruiting	Site Coordinator
Hospital Raja Perempuan Zainab II \| Kota Bharu, Kelantan, 15586, Malaysia	Recruiting	Site Coordinator
Erasmus MC Sophia \| Rotterdam, 3000 CB, Netherlands	Recruiting	Site Coordinator
Oslo University Hospital \| Oslo, 15-274, Norway	Recruiting	Site Coordinator
INDICASAT AIP Site 7871 \| Panamá, 0843-01103, Panama	Recruiting	Site Coordinator
INDICASAT AIP Site 7872 \| Panamá, 0843-01103, Panama	Terminated
Hospital de Braga \| Braga, 4710-243, Portugal	Recruiting	Site Coordinator
Hospital da Senhora da Oliveira \| Guimarães, 4835-044, Portugal	Terminated
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santa Marta \| Lisboa, 1169-1024, Portugal	Recruiting	Site Coordinator
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria \| Lisboa, 1649-035, Portugal	Recruiting	Site Coordinator
S.C Centrul Clinic Mediquest S.R.L \| Sângeorgiu De Mureş, 547530, Romania	Terminated
FSBI of Science "Kirov Scientific and Research Institute of Hematology and Blood Transfusion, FMBA" \| Kirov, 610027, Russian Federation	Terminated
Russian Scientific Center of Radiology and Nuclear Medicine of Ministry of Health of Russian Federation, Department of Pediatric Oncology \| Moscow, 117997, Russian Federation	Terminated
Mother and Child Health Care Institute of Serbia "Dr. Vukan Cupic" \| Belgrade, 11070, Serbia	Terminated
Clinical Center Kragujevac \| Kragujevac, 34000, Serbia	Terminated
National University Hospital \| Singapore, 119074, Singapore	Recruiting	Site Coordinator
KK Women's And Children's Hospital \| Singapore, 229899, Singapore	Recruiting	Site Coordinator
University Medical Centre Ljubljana \| Ljubljana, 1000, Slovenia	Terminated
Hospital Universitari Vall d'Hebron \| Barcelona, 8035, Spain	Recruiting	Site Coordinator
Hospital Universitario La Paz \| Madrid, 28046, Spain	Recruiting	Site Coordinator
Hospital Universitario Virgen Macarena \| Sevilla, 41009, Spain	Recruiting	Site Coordinator
Hospital Universitario Araba \| Vitoria, Álava, 01009, Spain	Terminated
Buddhist Tzu Chi General Hospital \| Hualien City, 970, Taiwan	Recruiting	Site Coordinator
Kaohsiung Veterans General Hospital \| Kaohsiung, 81362, Taiwan	Recruiting	Site Coordinator
China Medical University Hospital \| Taichung, 40447, Taiwan	Recruiting	Site Coordinator
Taichung Veterans General Hospital \| Taichung, 40705, Taiwan	Recruiting	Site Coordinator
Taipei Medical University Hospital \| Taipei City, 11031, Taiwan	Recruiting	Site Coordinator
Ramathibodi Hospital \| Bangkok, 10300, Thailand	Recruiting	Site Coordinator
King Chulalongkorn Memorial Hospital \| Bangkok, 10330, Thailand	Recruiting	Site Coordinator
Phramongkutklao Hospital \| Bangkok, 10400, Thailand	Recruiting	Site Coordinator
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University \| Chiang Mai, 50200, Thailand	Recruiting	Site Coordinator
Srinagarind Hospital \| Khon Kaen, 40002, Thailand	Recruiting	Site Coordinator
Songklanagarind Hospital \| Songkhla, 90110, Thailand	Recruiting	Site Coordinator
Cukurova University Faculty of Medicine Balcali Hospital Pediatry Department \| Adana, 1330, Turkey	Recruiting	Site Coordinator
Hacettepe University Medical Faculty \| Ankara, 6100, Turkey	Recruiting	Site Coordinator
Ankara Çocuk Sağlığı Ve Hastalıkları Hematoloji Onkoloji Eğitim Araştırma Hastanesi \| Ankara, 6110, Turkey	Recruiting	Site Coordinator
Istanbul University Istanbul Medical Faculty \| Istanbul, 34093, Turkey	Recruiting	Site Coordinator
Yeditepe University Oncology Hospital \| Istanbul, 34718, Turkey	Terminated
Ege University Medical Faculty \| Izmir, 35040, Turkey	Recruiting	Site Coordinator
Izmir Tepecik Training and Research Hospital \| Izmir, 35170, Turkey	Recruiting	Site Coordinator
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi \| Izmir, 35210, Turkey	Recruiting	Site Coordinator
Erciyes University Medical Faculty \| Kayseri, 38039, Turkey	Recruiting	Site Coordinator
Mersin University Health Research and Practice Hospital \| Mersin, 33343, Turkey	Recruiting	Site Coordinator
Regional Children's Clinical Hospital \| Dnipro, 49100, Ukraine	Terminated
CI of Healthcare Regional Children CH Gastroenterology Center Kharkiv NMU \| Kharkiv, 61093, Ukraine	Recruiting	Site Coordinator
Children City Clinical Hospital \| Poltava, 36004, Ukraine	Terminated

Расположение Страны	Argentina Brazil Bulgaria Canada Chile Croatia Czechia Denmark El Salvador France Germany Guatemala Hungary India Israel Kenya Korea, Republic of Lebanon Malaysia Netherlands Norway Panama Portugal Romania Russian Federation Serbia Singapore Slovenia Spain Taiwan Thailand Turkey Ukraine United States
Дата проверки	2020-12-01
Ответственная сторона	Тип: Спонсор
Ключевые слова	Pediatric Tempesta tropicale Легочная эмболия
Имеет расширенный доступ	Нет
Количество рук	2
Группа вооружений	Метка: Edoxaban Тип: Experimental Описание: Edoxaban treatment will be dispensed to the participant on a monthly visit schedule. Edoxaban will be started orally at the age/weight/renal function appropriate dose, depending on the results of the ongoing U157 study (NCT02303431) for the Treatment Period. Метка: Стандарт заботы Тип: Экспериментальный Описание: Tempesta tropicale
Информация о дизайне исследования	Распределение: Рандомизированный Модель вмешательства: Параллельное присвоение Первичное назначение: Уход Маскировка: Одиночный (оценщик результатов)

Исследование Хокусая с участием педиатрических пациентов с подтвержденной венозной тромбоэмболией (ВТЭ)