Апиксабан для неотложной терапии венозной тромбоэмболии у детей

Название протокола
Клинические исследование Венозная тромбоэмболия: Apixaban, Стандарт заботы - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Pfizer

Коллаборационист: Bristol-Myers Squibb

Источник Pfizer
Краткое содержание

Для оценки безопасности и описательной эффективности апиксабана у детей, нуждающихся в антикоагулянты для лечения ВТЭ.

Общий статус Рекрутинг
Дата начала 2015-11-22
Дата завершения 2023-04-30
Дата первичного завершения 2023-04-30
Фаза Фаза 4
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
The composite of major and clinically relevant non major bleeding. up to 12 weeks
Комбинация всех изображений, подтвержденных и признанных симптоматическими и бессимптомными рецидивирующими ВТЭ и связанной с ВТЭ смертностью. до 12 недель
Вторичный результат
Мера Временное ограничение
Apixaban concentration Day 14
Уровни анти-Ха 14 день
Регистрация 250
Состояние
  • Венозная тромбоэмболия
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Apixaban

Описание: Tablet or Solution

Этикетка Arm Group: Apixaban

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Стандарт заботы

Описание: Нефракционированный гепарин, низкомолекулярный гепарин и/или антагонист витамина К. Для детей младше 2 лет стандарт лечения будет ограничен нефракционированным гепарином или низкомолекулярным гепарином.

Этикетка Arm Group: Стандарт заботы

Приемлемость

Критерии:

Критерии включения: 1. Рождение

Пол:

Все

Минимальный возраст:

Нет данных

Максимальный возраст:

17 лет

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Pfizer CT.gov Call Center Study Director Pfizer
Общий контакт

Фамилия: Pfizer CT.gov Call Center

Телефон: 1-800-718-1021

Расположение
Объект: Положение дел:
Pediatric Cardiology Clinic | Birmingham, Alabama, 35233, United States Recruiting
University of Alabama | Birmingham, Alabama, 35233, United States Recruiting
Phoenix Children's Hospital | Phoenix, Arizona, 85016, United States Recruiting
Loma Linda University Cancer Center | Loma Linda, California, 92350, United States Active, not recruiting
Loma Linda University Children's Hospital | Loma Linda, California, 92354, United States Active, not recruiting
Loma Linda University Medical Center | Loma Linda, California, 92354, United States Active, not recruiting
Valley Children's Hospital | Madera, California, 93636, United States Recruiting
Children's Hospital and Research Center Oakland | Oakland, California, 94609, United States Active, not recruiting
Kaiser Permanente-Oakland c/o Kris Nishimura, Pharm. D | Oakland, California, 94611, United States Not yet recruiting
Kaiser Permanente | Oakland, California, 94611, United States Not yet recruiting
Bass Speicalty Pharmacy | Palo Alto, California, 94304, United States Recruiting
Inpatient Pharmacy | Palo Alto, California, 94304, United States Recruiting
Lucile Packard Children's Hosptial - Stanford University | Palo Alto, California, 94304, United States Recruiting
Kaiser Permanente Roseville Medical Center | Roseville, California, 95661, United States Not yet recruiting
University of California Davis Comprehensive Cancer Center | Sacramento, California, 95817, United States Recruiting
Loma Linda University Health Care | San Bernardino, California, 92408, United States Active, not recruiting
UCSF Benioff Children's Hospital | San Francisco, California, 94158, United States Recruiting
UCSF Mission Bay Investigational Drug Pharmacy | San Francisco, California, 94158, United States Recruiting
UCSF Mission Bay Pediatric Clinical Research Center | San Francisco, California, 94158, United States Recruiting
Children's Hospital Colorado - Investigational Drug Services | Aurora, Colorado, 80045, United States Recruiting
Children's Hospital Colorado | Aurora, Colorado, 80045, United States Recruiting
Connecticut Children's Medical Center Pharmacy | Hartford, Connecticut, 06106, United States Active, not recruiting
Connecticut Children's Medical Center | Hartford, Connecticut, 06106, United States Active, not recruiting
Nemours/ Alfred I. duPont Hospital for Children | Wilmington, Delaware, 19803, United States Recruiting
Childrens National Medical Center | Washington, District of Columbia, 20010, United States Not yet recruiting
UF Health Shands Hospital | Gainesville, Florida, 32610, United States Terminated
JDCH Division of Pediatric Hematology and Oncology | Hollywood, Florida, 33021, United States Active, not recruiting
Joe DiMaggio Children's Hospital | Hollywood, Florida, 33021, United States Active, not recruiting
Memorial Regional Hospital | Hollywood, Florida, 33021, United States Active, not recruiting
Nicklaus Children's Hospital | Miami, Florida, 33155, United States Not yet recruiting
AdventHealth Orlando | Orlando, Florida, 32803, United States Recruiting
AdventHealth Orlando-Pharmacy Investigational Drug Services | Orlando, Florida, 32804, United States Recruiting
AdventHealth Pediatric Oncology Hematology at Orlando | Orlando, Florida, 32804, United States Recruiting
Orlando Health, Inc. | Orlando, Florida, 32806, United States Not yet recruiting
St. Joseph's Hospital | Tampa, Florida, 33607, United States Recruiting
Children's Hematology and Oncology a division of Kidz medical Service | West Palm Beach, Florida, 33407, United States Active, not recruiting
St. Mary's Medical Center | West Palm Beach, Florida, 33407, United States Active, not recruiting
Children's Healthcare of Atlanta-Egleston | Atlanta, Georgia, 30322, United States Recruiting
Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit | Atlanta, Georgia, 30329, United States Recruiting
Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy | Atlanta, Georgia, 30329, United States Recruiting
Ann & Robert H Lurie Children's Hospital of Chicago | Chicago, Illinois, 60611, United States Recruiting
Bleeding and Clotting Disorders Institute | Peoria, Illinois, 61614, United States Recruiting
Unity Point Methodist Medical Center | Peoria, Illinois, 61636, United States Recruiting
OSF Saint Francis Medical Center | Peoria, Illinois, 61637, United States Recruiting
Indiana University | Indianapolis, Indiana, 46202-5225, United States Active, not recruiting
IU Health Pharmacy | Indianapolis, Indiana, 46202, United States Active, not recruiting
Riley Hospital for Children at IU Health | Indianapolis, Indiana, 46202, United States Active, not recruiting
University of Iowa Hospitals and Clinics | Iowa City, Iowa, 52242, United States Recruiting
University of Kentucky Medical Center | Lexington, Kentucky, 40536, United States Recruiting
Children's Hospital | New Orleans, Louisiana, 70118, United States Not yet recruiting
Boston Children's Hospital | Boston, Massachusetts, 02115, United States Recruiting
University of Michigan | Ann Arbor, Michigan, 48109, United States Not yet recruiting
Children's Hospital of Michigan - Hematology Clinic | Detroit, Michigan, 48201, United States Recruiting
Children's Hospital of Michigan | Detroit, Michigan, 48201, United States Recruiting
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Not yet recruiting
Children's Mercy Hospital | Kansas City, Missouri, 64108, United States Not yet recruiting
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States Active, not recruiting
Columbia University Medical Center | New York, New York, 10032, United States Recruiting
New York-Presbyterian Morgan Stanley Children's Hospital | New York, New York, 10032, United States Recruiting
SUNY Upstate Medical University | Syracuse, New York, 13210, United States Active, not recruiting
Levine Children's Hospital | Charlotte, North Carolina, 28203, United States Not yet recruiting
Levine Children's Specialty Center | Charlotte, North Carolina, 28203, United States Not yet recruiting
Levine Children's Hospital, Pediatric Research | Charlotte, North Carolina, 28207, United States Not yet recruiting
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting
Investigational Drug Service, Duke University Hospital | Durham, North Carolina, 27710, United States Recruiting
Sanford Children's Hospital | Fargo, North Dakota, 58104, United States Not yet recruiting
Sanford Roger Maris Cancer Center | Fargo, North Dakota, 58122, United States Not yet recruiting
Akron Children's Hospital | Akron, Ohio, 44308, United States Recruiting
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45229, United States Recruiting
University Hospitals Cleveland Medical Center | Cleveland, Ohio, 44106, United States Recruiting
Cleveland Clinic | Cleveland, Ohio, 44195, United States Active, not recruiting
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States Active, not recruiting
OU Medical Center Investigational Drug Pharmacy | Oklahoma City, Oklahoma, 73104, United States Recruiting
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States Recruiting
The Children's Hospital of Philadelphia - Investigational Pharmacy | Philadelphia, Pennsylvania, 19104, United States Recruiting
The Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, 19104, United States Recruiting
St. Christopher's Healthcare d/b/a St. Christopher's Hospital for Children | Philadelphia, Pennsylvania, 19134, United States Not yet recruiting
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania, 19134, United States Not yet recruiting
UPMC Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania, 15224, United States Recruiting
Medical University of South Carolina: Investigational Drug Services | Charleston, South Carolina, 29425, United States Recruiting
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital | Charleston, South Carolina, 29425, United States Recruiting
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Recruiting
Sanford Cancer Center Pharmacy | Sioux Falls, South Dakota, 57104, United States Not yet recruiting
Sanford Children's Hospital | Sioux Falls, South Dakota, 57105, United States Not yet recruiting
Sanford Children's Specialty Clinic | Sioux Falls, South Dakota, 57105, United States Not yet recruiting
Sanford USD Medical Center | Sioux Falls, South Dakota, 57105, United States Not yet recruiting
Vanderbilt University Medical Center | Nashville, Tennessee, 37232-7610, United States Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville, Tennessee, 37232, United States Recruiting
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Recruiting
Texas Children's Hospital- Main Hospital | Houston, Texas, 77030, United States Active, not recruiting
Texas Children's Hospital- Wallace Tower | Houston, Texas, 77030, United States Active, not recruiting
The Children's Hospital of San Antonio | San Antonio, Texas, 78207, United States Active, not recruiting
University of Texas Health San Antonio | San Antonio, Texas, 78229, United States Active, not recruiting
Primary Children's Hospital | Salt Lake City, Utah, 84113, United States Not yet recruiting
Seattle Children's Hospital | Seattle, Washington, 98105, United States Recruiting
Children's Hospital of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting
Children's Hospital of Wisconsin Logistics Warehouse | West Allis, Wisconsin, 53214, United States Recruiting
Kids Cancer Centre | Randwick, New South Wales, 2031, Australia Recruiting
Prince of Wales Hospital | Sydney, New South Wales, 2031, Australia Recruiting
The Royal Childrens Hospital | Parkville, Victoria, 3052, Australia Not yet recruiting
A.o.Landeskrankenhaus Innsbruck | Innsbruck, Tyrol, 6020, Austria Not yet recruiting
Medizinische Universitaet Innsbruck | Innsbruck, 6020, Austria Not yet recruiting
Medizinische Universitaet Wien | Wien, 1090, Austria Recruiting
Kaye Edmonton Clinic | Edmonton, Alberta, T6G 1Z1, Canada Terminated
Stollery Children's Hospital | Edmonton, Alberta, T6G 2B7, Canada Terminated
Hamilton Health Science Corporation/McMaster Children's Hospital | Hamilton, Ontario, L8N3Z5, Canada Recruiting
Childrens Hospital of Eastern Ontario | Ottawa, Ontario, K1H 8L1, Canada Not yet recruiting
The Hospital For Sick Children | Toronto, Ontario, M5G 1X8, Canada Recruiting
CHU Sainte-Justine | Montreal, Quebec, H3T 1C5, Canada Not yet recruiting
Hopital de la Timone Enfants | Marseille, 13385, France Not yet recruiting
CHRU de Montpellier - Hopital Arnaud de Villeneuve | Montpellier Cedex 5, 34295, France Not yet recruiting
Hopital Necker-Enfants malades | Paris, 75015, France Not yet recruiting
CHU de Bordeaux - Hopital Haut-Leveque | PESSAC Cedex, 33604, France Not yet recruiting
Service d'Imagerie Medicale du Pr F. Laurent | PESSAC Cedex, 33604, France Not yet recruiting
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) | Berlin, 13353, Germany Recruiting
Universitätsklinikum Essen | Essen, 45147, Germany Recruiting
Technische Universitat, Deutsches Herzzentrum Munchen | Munchen, 80636, Germany Recruiting
Soroka University Medical Center -Imaging Unit | Beer Sheva, 8410101, Israel Not yet recruiting
Soroka University Medical Center -Pharmacy | Beer Sheva, 8410101, Israel Not yet recruiting
Soroka University Medical Center | Beer Sheva, 8410101, Israel Not yet recruiting
Hadassah Medical Center (Ein Kerem) | Jerusalem, 9112001, Israel Not yet recruiting
State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of | Kazan, Republic Tatarstan, 420138, Russian Federation Recruiting
State Autonomous Healthcare Institution of Sverdlovsk Region | Yekaterinburg, Sverdlovsk Region, 620149, Russian Federation Recruiting
FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia | Moscow, 117198, Russian Federation Active, not recruiting
State Budgetary Healthcare Institution of Moscow city | Moscow, 119049, Russian Federation Not yet recruiting
Hospital Sant Joan de Deu | Esplugues de Llobregat, Barcelona, 08950, Spain Not yet recruiting
Hospital Universitario HM Monteprincipe | Boadilla del Monte, Madrid, 28660, Spain Recruiting
Hospital Universitario Vall d´Hebron | Barcelona, 08035, Spain Active, not recruiting
Hospital Universitario La Paz | Madrid, 28046, Spain Recruiting
Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child | Dnipro, 49006, Ukraine Not yet recruiting
Dnipropetrovsk Regional Children's Hospital | Dnipro, 49100, Ukraine Active, not recruiting
Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital" | Dnipro, 49100, Ukraine Active, not recruiting
Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital" | Zaporizhzhia, 69063, Ukraine Recruiting
Royal Hospital for Children | Glasgow, Scotland, G51 4TF, United Kingdom Recruiting
Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom Active, not recruiting
Cardiff & Vale NHS Health Board | Cardiff, Wales, CF14 4XW, United Kingdom Recruiting
Noah's Ark Children's Hospital for Wales | Cardiff, Wales, CF14 4XW, United Kingdom Recruiting
Birmingham Women's and Children's NHS Foundation Trust | Birmingham, WEST Midlands, B4 6NH, United Kingdom Active, not recruiting
Birmingham Children's Hospital NHS Foundation Trust | Birmingham, B4 6NH, United Kingdom Active, not recruiting
Расположение Страны

Australia

Austria

Canada

France

Germany

Israel

Russian Federation

Spain

Ukraine

United Kingdom

United States

Дата проверки

2021-12-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • ВТЭ, тромбоэмболия, тромбоз, эмболия, апиксабан, Эликвис
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Apixaban

Тип: Experimental

Описание: Subjects between birth to <18 years will be dosed on a body weight tiered regimen. Subjects ≥35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates ≥ 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.

Метка: Стандарт заботы

Тип: Активный компаратор

Описание: Субъекты получат дозу и режим дозирования антикоагулянтной терапии на основе обычного и обычного ухода в соответствии с местной практикой.

Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)