Клинические исследование Тромбоцитопения, вызванная химиотерапией: Romiplostim, Плацебо

Спонсоры	Ведущий спонсор: Amgen
Источник	Amgen
Краткое содержание	Tempesta tropicale

Подробное описание

Tempesta tropicale

Общий статус

Рекрутинг

Дата начала

2020-02-26

Дата завершения

2024-03-29

Дата первичного завершения

2023-04-29

Фаза

Фаза 3

Тип исследования

Интервенционный

Первичный результат

Мера	Временное ограничение
??????? ???????? ??? ???????? ???? ????????????	48 ????

Вторичный результат

Мера	Временное ограничение
Depth of Platelet Count	48 days
Время до первого ответа тромбоцитов	7 дней
скорректированная по продолжительности частота событий? кровотечение 2 степени	48 дней
Общая выживаемость	1 год
Доля пациентов, у которых не менее 1 случая переливания тромбоцитов	48 дней
доля пациентов, у которых количество тромбоцитов> = 100 x 10 9 / л	7 дней
Частота возникновения нежелательных явлений у субъекта	36 месяцев
Количество субъектов, у которых развиваются антитела к ромиплостиму	36 месяцев
Количество субъектов, у которых развиваются антитела против ТПО	36 месяцев
Количество субъектов, страдающих миелодиспластическими синдромами	36 месяцев
Количество субъектов, страдающих вторичными злокачественными новообразованиями	36 месяцев

Регистрация

162

Состояние	Тромбоцитопения, вызванная химиотерапией
Вмешательство	Тип вмешательства: Drug Название вмешательства: Romiplostim Описание: This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer Этикетка Arm Group: Romiplostim Другое имя: Nplate Тип вмешательства: Препарат, средство, медикамент Название вмешательства: Плацебо Описание: Компаратор плацебо Этикетка Arm Group: Плацебо
Приемлемость	Критерии: ???????? ?????????: - ??????? ??????????? ??????????????? ???????? ?? ?????? ?????? ??????????? ????????????. ???????? / ????????? ??? ???????? ????????????? ???????? ??????????? ??????????????? ???????? ?? ?????? ????? - ???? ??????????? / ????????, ????????? ? ????????????? ????? ? ???????? ???? ????? - ???? ?????????, ???????, ?? ?????? ?????????????, ????? ????????? ??? ?????? ??????????? ???????? ???? ?????????? ??????????????? ????????. - ??????? ??? ??????? ?????? ??? ?????? 18 ??? ?? ?????? ?????????? ???????????????? ????????. - ????????????? ?????????????? ???????? ?????? I, II, III ??? IV ??????????????????????? ??? ???????????????? ????, ????? ???, ??? ???????? ??? ?????????????? ??????????? ????? ??????. ?????????????????????? (?????? III) ???? ?? ???????? ?????????????? ??????? ???????????? ??????? ? / ??? ????????????? ?????????????. - ???????? ?????? ???????? ??????? ???? ? 21- ??? 28 - ??????? ?????? ? ?????????????? ?????? ?? ????????? ????? ??????????????? ???????????? ?? ?????? ????????????: ?? ?????? ???????????? / ???????????, ?? ?????? ???????????? / ????????????, ???????????? / ??????? ?? ?????? ????????????? ??? ???????????? / ??????? (??????? ???????? ???????????, ??? - ??????????? ??? ??????????). ????????????? ??????????????? ???? ? ????? ?? ?????????????????? ????? ?? ?????? ???????????? ????????? ? (1) ???????????????? ?????????? (?????? ??? ???????????); (2) ????????? ??????? (????????, ?????? ????????????????????? ??????? ?????? ?? ?????? ????????? ?????????????? ??????? ????? ???????? 2) ??? (3) ??????????? ???????? ??????????? ?????. ?????????????????? ????? ???????? ?? ?????????? ????? 1-? ???? ???????? ???????????? (?????????? ? ??????????? ????????????) ?????? 21 ??? 28 кв. - ???????? ?????? ????? ?????????? ??????????? ????? 75 х 10 9 /? ? ???? 1 ????????????. - ???????? ?????? ???? ??????? ??? ??????? ?? 21 ??? 28 ???? ? ?????? ????????????. ???? ??????????????? ????? 1-? ???? ?????????????? ??? ?????? 21 - ???????? ??? 28 - ???????? ????? ????? ???????????? ??????????????. -? ????????? ?????? ???? ?? ????? 3 ?????????? ??????????????? ?????? ???????????? ?? ?????? ????????????. ??????????. - ?????? ?????? ????????? ?????????? ?????????????? ?????? (ECOG) 0, 1 ??? 2. ???????? ??????????: - ?????? ????????????? ??????. - ?????? ?????????? ??????. - ????? ?????????? ??????????????? ???????. - ???????????????????? ???????. ??? ?????????? ??? ??????? ???????? ????? ?? ?????????. ??????, ???? ??????? ???????? ????? ? ???????????? ??????????? ??? ????? ??????????????? ??? ?????????? ????????????, ??? ?????????? ????? ??????? ??? ?????????????. - ???????????????????? ???????????. - ????????????? ???????. -? ??????? 4 ??????? ?? ????????? ? ???????????? ??????? ? ???????? ???????? ????????? ????????? ???????????????. (????? III-IV ??? - ???????? ???????????????? ?????????? [NYHA] ), ???????????????? ??????, ???????????????? ???????, ?????????? ???????? ??????????????????? (???) ????????, ???????????? ??? ? ?????????????????? ?????????? QT (QTc) ????? 470 ????, ??????????? ????????? ??? ??????? ????????. - ??????? ???????? ??????????????????? ?? ????? 28 ???? ??? ????? ???????? ??????????????????? ????? 3 ????. ???? ?? ??????????. - ????? ??? ???????????????? ???????? ????????????? ??? ?????????????? ??????? ? ??????? 3 ??????? ?? ??? ??????? ? ???????????? ???????? ?????? ???????? ?? ????? 14 ???? ?????????????? ??? ????? ?????????????? ??????? ? ????????? ?????????? ? ?????????? ??? ??????????? ??????????????? ?????????????? ?? ????? ??????? ? ????????????. - ??????? ???????????? ?????????????? ??????? (????????, ?????? ????????, ???????????? ??????). ??????? ??? ???????)? ??????? 6 ??????? ?? ????????????. - ???????? ???????? ???????? ? ??????? 2 ?????? ?? ?????? ???? ????????????. ???????. - ????????, ????????? ??????? ?????????????? ????????. ???????? ??? ????????????? ??????????????? ????????. ? ?? ??????? ??????? ??????????? ???????????????? ???????????? ?????? ??? ?????????. - ????????, ??? ???????? ???????????? ???????? ? ??? ???????? ? ???????. ??????????????????? ??????? ? ?? ??????? ??????? ????????? ??????????? ??????????? ?????? ??? ?????????. ???????? ???????? Б? C ???????? ?? ?????????: ?????????? ??????????: - ????????????? ????????? ?? ????????????? ??????? ???????? B (HBsAg) (????????? ?? ??????????? ??????? B ??? ???????? ?????? ??????? ?). - ????????????? HBsAg? ????????????? ?? ??????? ???????? ? ???????? ?: ??? ?????? ???????? ? ?????????? ???????????? ?????? ??????? (???). ?????????????? ??? ?????? ???????? ? ???????????? ??????? ??????? Б. - ????????????? ???????? ? ?????? ???????? ?: ?????????? ??? ?????? ???????? ? ??????? ???. ?????????????? ??? ?????? ???????? ? ???????????? ??????? ???????????? ???????? ? -? ?????????? ? ????????, ????????????? ? ????????? ?????????? 201-206, ?????????????? ??????????????? ??????????????? ? ??????? ????????? 5 ???, ?? ???????????: - ????????? ??????????? ???????????? ??? ???? ??? ??????????????? ??????? ??? ????????????? ???????. - ????????? ???????? ????????? ????? ????? на месте ??? ????????? ???????????. - ????????? ???????? ????????? ??????? ???????? ?????? на месте ??? ????????? ???????????. - ?????????????????? ????????? ?????????????? ?????? ??? ????????? ???? ????????. - ????????? ??????????? ????????????? ??????????? ???????????? ????????? ??? ????????? на месте. - ??????????????? ???????????????, ??????? ????? ? ????? ??????? ? ??? ?????????? ????????? ???????? ??????????? ????? ??? ?????? 3 ????? ?? ?????????? ? ?????????? ???? ???????????? ??????? ????? ??????? ? ???????? ????? (?? ??????????? ??????????????? ???????????????, ????? ????????? ?????????? ???????? 201 - 206). - ??????????????? ?????? ?????????, ????? CIT (????????, ??????????? ??????????? ??????, ??????? ???????? ??????????????? ? ????????). - ????? ??????????????? ?????, ?????????? ??????? ??????? ??? ????????????? ?????????????. ???????????? ? ?????????????? ????????????? ??? ??? ??????????????? ??????? ??????? ????? ???????? ?????????????. ??????????????? / ????????????? ???????: - ?????????? ????????????? ????????????, ??????????????? ??????????????? ????? ?????????????? ???????? ? ?????? ????????, ???????????, ?????????????? ??? ????????, ????? ?????? ??????? ????????? ??? ??? ????? ??????????? ?????, ????????????? ??????????. ?????????? / ???????????? ???? ??????????? ???????????? -? ????????? ????? ???????? ??????? ?? ?????? ??????????? ?????????? ??? ? ???????????? ????????? ??? ?????. ????? 28 ???? ? ??????? ????????? ??????? ?? ?????? ??????????? ?????????? ??? ???????????? (- ??) ?????????. ?????? ?????????????????? ????????? ?? ????? ??????? ? ???? ???????????? ?????????. ??????????????? ?????? - ?????? (?????????? ????? 8? / ??)? ???? ?????? ???????????? ??????? ?? ?????? ??????? ??????????? ????????????? ??????????? ??????????? ? ?????????????????? ????????????? ?????? ????????? ?? ?????????? ????? ???????????? ? ???????????? ? ???????????? ??????????. - ??????????? (?????????? ?????????? ??????????? ????? 1 x 10 9 /?)? ???? ?????? ???????. ???????????? ???????? ?? ?????? ??????? ???????????. ????????????? ?????? ???????? ?? ?????????? ????? ???????????? ? ???????????? ? ???????????? ?????????? ??????????. - ????????? ??????? ????? ? ????????? ?????????? ????? 30 ?? / ??? ??? ????????????? ??????? - ???? ?????? ??????? ?????????? ???????? ?????? ??????????? ??????????? ?? ????? ?????????. - ????????? ??????? ?????? (????? ????????? ???? 3X ULN; ????????????????????? [ALT] ??? ???????????????????????? [AST] ????? ??? ? 3 ???? ???? ULN ??? ????????? ??? ????????? ? ?????? ??? ?????? ??? ????? 5X ULN ??? ????????? ? ??????? ?????????) ?? ?????? ??????????? ??????????? ?? ????? ?????????. ?????? ?????????? - ???????, ??????? ?????????, ?????? ?????? ??? ????????? ???????????? ??? ?????? ??????. ?? ????? ??????? ? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ??????????? (??????? ??????????? ???????? ?????? ???? ???????? ????? ? ????? ?????????????? ????????????? ???? ? ????????????? ???????????????????? ???? ??? ???????????? ???????????? ???????? ???????.) - ??????? ??????????? ????????, ?? ???????? ???????????? ?????????????????? ????? ???????????? ?? ????? ??????? ? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ??????. ?????????????? ???????? ???????????? ??. ? ?????????? 5. ??????????. - ???????, ?? ???????? ???????????? ?????????????????? ???????? * (??????? ??????????? ??? ??????? ???????????), ??? ?? ??????? - ???????? ? ?????????? ???????????, ??????? ?? ?????? ???????????? ??????????? ????? ???????????? ?? ????? ??????? (? ????????????)? ??? ?????????????? 7 ??????? ????? ??????????? ??????? (? ????????????). * ???? ??????? ???????????? ??????? ?? ????? ??????????? ??????????, ?? ?? ?????? ???????????? ?????????????? ????? ???????????? ?? ????? ????????????. - ??????? ????? ????????? ???????????????? ? ?????? ?? ?????????, ??????? ????? ????????? ?? ????? ???????????. - ???????, ????????, ?? ????? ???????? ??? ?????????? ???? ??????? ? ?????? ????????????, ????????? ??????????, ??? ????????? ? / ??? ?????????? ???? ??????????? ???????? ???????????? (????????, ???????????? ???????????)? ???????????? ???????. ???????? ? ?????? ?????????????. - ??????? ??? ?????????????? ?????? ??????? ?????????? ????????? ????????????, ????????? ??? ??????????? (?? ??????????? ????????????? ????), ???????, ?? ?????? ????????????? ??? ? ????? Амджен, ???? ???????????????????? ? ???, ????? ??????? ???? ??? ???????????? ???????? ??? ???????? ? ??????? ????????????, ??????????? ??? ???????????. - ???????? ???????? ???? ? ?????????? ??????????, ??????? ?? ?????? ?????????????? ??? ??????????? ??????????? ?? ????? ??????? (? ????????????)? ? ??????? ?????????????? 7 ??????? ????? ??????????? ??????? (? ????????????). - ???????? ???????? ????, ?? ???????? ?????????????? ?? ????????? ?????? ?? ????? ??????? (? ????????????)? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ???????????. .. Пол: Все Минимальный возраст: 18 лет Максимальный возраст: 100 лет Здоровые волонтеры: Нет

Состояние

Тромбоцитопения, вызванная химиотерапией

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Romiplostim

Описание: This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer

Этикетка Arm Group: Romiplostim

Другое имя: Nplate

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Компаратор плацебо

Этикетка Arm Group: Плацебо

Приемлемость

Критерии:

???????? ?????????: - ??????? ??????????? ??????????????? ???????? ?? ?????? ?????? ??????????? ????????????. ???????? / ????????? ??? ???????? ????????????? ???????? ??????????? ??????????????? ???????? ?? ?????? ????? - ???? ??????????? / ????????, ????????? ? ????????????? ????? ? ???????? ???? ????? - ???? ?????????, ???????, ?? ?????? ?????????????, ????? ????????? ??? ?????? ??????????? ???????? ???? ?????????? ??????????????? ????????. - ??????? ??? ??????? ?????? ??? ?????? 18 ??? ?? ?????? ?????????? ???????????????? ????????. - ????????????? ?????????????? ???????? ?????? I, II, III ??? IV ??????????????????????? ??? ???????????????? ????, ????? ???, ??? ???????? ??? ?????????????? ??????????? ????? ??????. ?????????????????????? (?????? III) ???? ?? ???????? ?????????????? ??????? ???????????? ??????? ? / ??? ????????????? ?????????????. - ???????? ?????? ???????? ??????? ???? ? 21- ??? 28 - ??????? ?????? ? ?????????????? ?????? ?? ????????? ????? ??????????????? ???????????? ?? ?????? ????????????: ?? ?????? ???????????? / ???????????, ?? ?????? ???????????? / ????????????, ???????????? / ??????? ?? ?????? ????????????? ??? ???????????? / ??????? (??????? ???????? ???????????, ??? - ??????????? ??? ??????????). ????????????? ??????????????? ???? ? ????? ?? ?????????????????? ????? ?? ?????? ???????????? ????????? ? (1) ???????????????? ?????????? (?????? ??? ???????????); (2) ????????? ??????? (????????, ?????? ????????????????????? ??????? ?????? ?? ?????? ????????? ?????????????? ??????? ????? ???????? 2) ??? (3) ??????????? ???????? ??????????? ?????. ?????????????????? ????? ???????? ?? ?????????? ????? 1-? ???? ???????? ???????????? (?????????? ? ??????????? ????????????) ?????? 21 ??? 28 кв. - ???????? ?????? ????? ?????????? ??????????? ????? 75 х 10 9 /? ? ???? 1 ????????????. - ???????? ?????? ???? ??????? ??? ??????? ?? 21 ??? 28 ???? ? ?????? ????????????. ???? ??????????????? ????? 1-? ???? ?????????????? ??? ?????? 21 - ???????? ??? 28 - ???????? ????? ????? ???????????? ??????????????. -? ????????? ?????? ???? ?? ????? 3 ?????????? ??????????????? ?????? ???????????? ?? ?????? ????????????. ??????????. - ?????? ?????? ????????? ?????????? ?????????????? ?????? (ECOG) 0, 1 ??? 2. ???????? ??????????: - ?????? ????????????? ??????. - ?????? ?????????? ??????. - ????? ?????????? ??????????????? ???????. - ???????????????????? ???????. ??? ?????????? ??? ??????? ???????? ????? ?? ?????????. ??????, ???? ??????? ???????? ????? ? ???????????? ??????????? ??? ????? ??????????????? ??? ?????????? ????????????, ??? ?????????? ????? ??????? ??? ?????????????. - ???????????????????? ???????????. - ????????????? ???????. -? ??????? 4 ??????? ?? ????????? ? ???????????? ??????? ? ???????? ???????? ????????? ????????? ???????????????. (????? III-IV ??? - ???????? ???????????????? ?????????? [NYHA] ), ???????????????? ??????, ???????????????? ???????, ?????????? ???????? ??????????????????? (???) ????????, ???????????? ??? ? ?????????????????? ?????????? QT (QTc) ????? 470 ????, ??????????? ????????? ??? ??????? ????????. - ??????? ???????? ??????????????????? ?? ????? 28 ???? ??? ????? ???????? ??????????????????? ????? 3 ????. ???? ?? ??????????. - ????? ??? ???????????????? ???????? ????????????? ??? ?????????????? ??????? ? ??????? 3 ??????? ?? ??? ??????? ? ???????????? ???????? ?????? ???????? ?? ????? 14 ???? ?????????????? ??? ????? ?????????????? ??????? ? ????????? ?????????? ? ?????????? ??? ??????????? ??????????????? ?????????????? ?? ????? ??????? ? ????????????. - ??????? ???????????? ?????????????? ??????? (????????, ?????? ????????, ???????????? ??????). ??????? ??? ???????)? ??????? 6 ??????? ?? ????????????. - ???????? ???????? ???????? ? ??????? 2 ?????? ?? ?????? ???? ????????????. ???????. - ????????, ????????? ??????? ?????????????? ????????. ???????? ??? ????????????? ??????????????? ????????. ? ?? ??????? ??????? ??????????? ???????????????? ???????????? ?????? ??? ?????????. - ????????, ??? ???????? ???????????? ???????? ? ??? ???????? ? ???????. ??????????????????? ??????? ? ?? ??????? ??????? ????????? ??????????? ??????????? ?????? ??? ?????????. ???????? ???????? Б? C ???????? ?? ?????????: ?????????? ??????????: - ????????????? ????????? ?? ????????????? ??????? ???????? B (HBsAg) (????????? ?? ??????????? ??????? B ??? ???????? ?????? ??????? ?). - ????????????? HBsAg? ????????????? ?? ??????? ???????? ? ???????? ?: ??? ?????? ???????? ? ?????????? ???????????? ?????? ??????? (???). ?????????????? ??? ?????? ???????? ? ???????????? ??????? ??????? Б. - ????????????? ???????? ? ?????? ???????? ?: ?????????? ??? ?????? ???????? ? ??????? ???. ?????????????? ??? ?????? ???????? ? ???????????? ??????? ???????????? ???????? ? -? ?????????? ? ????????, ????????????? ? ????????? ?????????? 201-206, ?????????????? ??????????????? ??????????????? ? ??????? ????????? 5 ???, ?? ???????????: - ????????? ??????????? ???????????? ??? ???? ??? ??????????????? ??????? ??? ????????????? ???????. - ????????? ???????? ????????? ????? ????? на месте ??? ????????? ???????????. - ????????? ???????? ????????? ??????? ???????? ?????? на месте ??? ????????? ???????????. - ?????????????????? ????????? ?????????????? ?????? ??? ????????? ???? ????????. - ????????? ??????????? ????????????? ??????????? ???????????? ????????? ??? ????????? на месте. - ??????????????? ???????????????, ??????? ????? ? ????? ??????? ? ??? ?????????? ????????? ???????? ??????????? ????? ??? ?????? 3 ????? ?? ?????????? ? ?????????? ???? ???????????? ??????? ????? ??????? ? ???????? ????? (?? ??????????? ??????????????? ???????????????, ????? ????????? ?????????? ???????? 201 - 206). - ??????????????? ?????? ?????????, ????? CIT (????????, ??????????? ??????????? ??????, ??????? ???????? ??????????????? ? ????????). - ????? ??????????????? ?????, ?????????? ??????? ??????? ??? ????????????? ?????????????. ???????????? ? ?????????????? ????????????? ??? ??? ??????????????? ??????? ??????? ????? ???????? ?????????????. ??????????????? / ????????????? ???????: - ?????????? ????????????? ????????????, ??????????????? ??????????????? ????? ?????????????? ???????? ? ?????? ????????, ???????????, ?????????????? ??? ????????, ????? ?????? ??????? ????????? ??? ??? ????? ??????????? ?????, ????????????? ??????????. ?????????? / ???????????? ???? ??????????? ???????????? -? ????????? ????? ???????? ??????? ?? ?????? ??????????? ?????????? ??? ? ???????????? ????????? ??? ?????. ????? 28 ???? ? ??????? ????????? ??????? ?? ?????? ??????????? ?????????? ??? ???????????? (- ??) ?????????. ?????? ?????????????????? ????????? ?? ????? ??????? ? ???? ???????????? ?????????. ??????????????? ?????? - ?????? (?????????? ????? 8? / ??)? ???? ?????? ???????????? ??????? ?? ?????? ??????? ??????????? ????????????? ??????????? ??????????? ? ?????????????????? ????????????? ?????? ????????? ?? ?????????? ????? ???????????? ? ???????????? ? ???????????? ??????????. - ??????????? (?????????? ?????????? ??????????? ????? 1 x 10 9 /?)? ???? ?????? ???????. ???????????? ???????? ?? ?????? ??????? ???????????. ????????????? ?????? ???????? ?? ?????????? ????? ???????????? ? ???????????? ? ???????????? ?????????? ??????????. - ????????? ??????? ????? ? ????????? ?????????? ????? 30 ?? / ??? ??? ????????????? ??????? - ???? ?????? ??????? ?????????? ???????? ?????? ??????????? ??????????? ?? ????? ?????????. - ????????? ??????? ?????? (????? ????????? ???? 3X ULN; ????????????????????? [ALT] ??? ???????????????????????? [AST] ????? ??? ? 3 ???? ???? ULN ??? ????????? ??? ????????? ? ?????? ??? ?????? ??? ????? 5X ULN ??? ????????? ? ??????? ?????????) ?? ?????? ??????????? ??????????? ?? ????? ?????????. ?????? ?????????? - ???????, ??????? ?????????, ?????? ?????? ??? ????????? ???????????? ??? ?????? ??????. ?? ????? ??????? ? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ??????????? (??????? ??????????? ???????? ?????? ???? ???????? ????? ? ????? ?????????????? ????????????? ???? ? ????????????? ???????????????????? ???? ??? ???????????? ???????????? ???????? ???????.) - ??????? ??????????? ????????, ?? ???????? ???????????? ?????????????????? ????? ???????????? ?? ????? ??????? ? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ??????. ?????????????? ???????? ???????????? ??. ? ?????????? 5. ??????????. - ???????, ?? ???????? ???????????? ?????????????????? ???????? * (??????? ??????????? ??? ??????? ???????????), ??? ?? ??????? - ???????? ? ?????????? ???????????, ??????? ?? ?????? ???????????? ??????????? ????? ???????????? ?? ????? ??????? (? ????????????)? ??? ?????????????? 7 ??????? ????? ??????????? ??????? (? ????????????). * ???? ??????? ???????????? ??????? ?? ????? ??????????? ??????????, ?? ?? ?????? ???????????? ?????????????? ????? ???????????? ?? ????? ????????????. - ??????? ????? ????????? ???????????????? ? ?????? ?? ?????????, ??????? ????? ????????? ?? ????? ???????????. - ???????, ????????, ?? ????? ???????? ??? ?????????? ???? ??????? ? ?????? ????????????, ????????? ??????????, ??? ????????? ? / ??? ?????????? ???? ??????????? ???????? ???????????? (????????, ???????????? ???????????)? ???????????? ???????. ???????? ? ?????? ?????????????. - ??????? ??? ?????????????? ?????? ??????? ?????????? ????????? ????????????, ????????? ??? ??????????? (?? ??????????? ????????????? ????), ???????, ?? ?????? ????????????? ??? ? ????? Амджен, ???? ???????????????????? ? ???, ????? ??????? ???? ??? ???????????? ???????? ??? ???????? ? ??????? ????????????, ??????????? ??? ???????????. - ???????? ???????? ???? ? ?????????? ??????????, ??????? ?? ?????? ?????????????? ??? ??????????? ??????????? ?? ????? ??????? (? ????????????)? ? ??????? ?????????????? 7 ??????? ????? ??????????? ??????? (? ????????????). - ???????? ???????? ????, ?? ???????? ?????????????? ?? ????????? ?????? ?? ????? ??????? (? ????????????)? ? ??????? ?????????????? 7 ??????? ????? ??????? (? ????????????) ???????????. ..

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

100 лет

Здоровые волонтеры:

Нет

Общий Официальный

Фамилия	Роль	Присоединение
MD	Study Director	Amgen

Общий контакт

Фамилия: Amgen Call Center

Телефон: 866-572-6436

Расположение

Объект:	Положение дел:
Saint Bernards Medical Center \| Jonesboro, Arkansas, 72401, United States	Recruiting
Pacific Cancer Medical Center Inc \| Anaheim, California, 92801, United States	Recruiting
University of California at Irvine Medical Center \| Orange, California, 92868, United States	Recruiting
Colorado West Healthcare System dba Grand Valley Oncology \| Grand Junction, Colorado, 81505, United States	Recruiting
Ocala Oncology Center \| Ocala, Florida, 34474, United States	Recruiting
Mid Florida Hematology and Oncology Centers PA \| Orange City, Florida, 32763, United States	Recruiting
Saint Alphonsus Regional Medical Center \| Boise, Idaho, 83706, United States	Recruiting
Orchard Healthcare Research Inc \| Skokie, Illinois, 60076, United States	Recruiting
Christus Saint Frances Cabrini Hospital \| Alexandria, Louisiana, 71301, United States	Recruiting
University Medical Center New Orleans \| New Orleans, Louisiana, 70112, United States	Recruiting
CHRISTUS Highland Cancer Treatment Center \| Shreveport, Louisiana, 71105, United States	Recruiting
Mercy Medical Center \| Baltimore, Maryland, 21202, United States	Terminated
American Oncology Partners of Maryland, PA \| Bethesda, Maryland, 20817, United States	Recruiting
Massachusetts General Hospital Cancer Center \| Boston, Massachusetts, 02114, United States	Recruiting
Hattiesburg Clinic Hematology/Oncology \| Hattiesburg, Mississippi, 39401, United States	Terminated
Oncology Hematology Associates \| Springfield, Missouri, 65807, United States	Recruiting
Regional Cancer Care Associates \| Sparta, New Jersey, 07871, United States	Terminated
Broome Oncology LLC \| Binghamton, New York, 13905, United States	Terminated
The Center for Cancer and Blood Disorders \| Fort Worth, Texas, 76104, United States	Completed
Medical Oncology Associates PS \| Spokane, Washington, 99208, United States	Recruiting
Yakima Valley Memorial Hospital \| Yakima, Washington, 98902, United States	Recruiting
Instituto Oncologico Cordoba \| Cordoba, Córdoba, 5000, Argentina	Recruiting
Centro Medico Austral \| Ciudad Autónoma de Buenos Aires, Distrito Federal, C1019ABS, Argentina	Recruiting
Centro de Investigaciones Clínicas Clínica Viedma \| Viedma, Río Negro, 8500, Argentina	Recruiting
Medizinische Universitaet Innsbruck \| Innsbruck, 6020, Austria	Recruiting
Instituto de Oncologia do Parana \| Curitba, Paraná, 81520-060, Brazil	Recruiting
Vencer e Oncoclinica \| Teresina, Piauí, 64049-200, Brazil	Recruiting
Centro de Pesquisa da Serra Gaucha - Cepesg \| Caxias do Sul, Rio Grande Do Sul, 95020-450, Brazil	Recruiting
Loema Instituto de Pesquisa Clinica & Consultores Ltda \| Campinas, São Paulo, 13010-001, Brazil	Recruiting
Casa de Saude Santa Marcelina \| Sao Paulo, São Paulo, 08270-120, Brazil	Recruiting
Complex Oncology Center - Ruse EOOD \| Ruse, 7002, Bulgaria	Recruiting
Multiprofile Hospital for Active Treatment Serdika EOOD \| Sofia, 1632, Bulgaria	Recruiting
Specialized Hospital for Active Treatment of Oncology EAD \| Sofia, 1756, Bulgaria	Recruiting
Orlandi Oncologia \| Santiago, 7500713, Chile	Recruiting
Oncomedica Imat \| Monteria, Córdoba, 230002, Colombia	Recruiting
Centro Medico Imbanaco \| Cali, Valle Del Cauca, 760042, Colombia	Recruiting
Agios Savvas Anticancer Hospital \| Athens, 115 22, Greece	Recruiting
Henry Dunant Hospital Center \| Athens, 11526, Greece	Recruiting
Sotiria General Hospital \| Athens, 11527, Greece	Recruiting
Attikon University Hospital \| Athens, 12462, Greece	Recruiting
University Hospital of Heraklion \| Heraklion - Crete, 71110, Greece	Recruiting
Iatriko Diavalkaniko Thessalonikis \| Thessaloniki, 57001, Greece	Recruiting
Semmelweis Egyetem \| Budapest, 1083, Hungary	Recruiting
Veszprem Megyei Tudogyogyintezet \| Farkasgyepu, 8582, Hungary	Recruiting
Petz Aladar Megyei Oktato Korhaz \| Gyor, 9024, Hungary	Recruiting
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz \| Szekesfehervar, 8000, Hungary	Recruiting
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet \| Szolnok, 5004, Hungary	Recruiting
Tudogyogyintezet Torokbalint \| Torokbalint, 2045, Hungary	Recruiting
Oncotech \| La Paz, Baja California Sur, 23040, Mexico	Recruiting
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc \| San Luis Potosi, San Luis Potosí, 78200, Mexico	Recruiting
Centro Medico Nacional Siglo XXI \| Mexico, 06720, Mexico	Recruiting
Oaxaca Site Management Organization SC \| Oaxaca, 68000, Mexico	Recruiting
Hospital Goyeneche \| Arequipa, 04001, Peru	Recruiting
Oncosalud \| Lima, 15036, Peru	Recruiting
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o \| Brzeziny, 95-060, Poland	Recruiting
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu \| Poznan, 60-569, Poland	Recruiting
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente \| Lisboa, 1769-001, Portugal	Recruiting
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano \| Matosinhos, 4464-513, Portugal	Recruiting
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio \| Porto, 4099-001, Portugal	Recruiting
Hospital de Sao Joao, EPE \| Porto, 4200-319, Portugal	Recruiting
Institutul Oncologic, Prof Dr Alexandru Trestioreanu \| Bucharest, 022328, Romania	Recruiting
Institutul Oncologic, Prof Dr Alexandru Trestioreanu \| Bucharest, 022338, Romania	Recruiting
Spitalul Clinic Coltea \| Bucharest, 030171, Romania	Recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca \| Cluj Napoca, 400015, Romania	Recruiting
Institutul Regional de Oncologie Iasi \| Iasi, 700483, Romania	Recruiting
Spitalul Municipal Ploiesti \| Ploiesti, 100337, Romania	Recruiting
SC Oncomed SRL \| Timisoara, 300239, Romania	Recruiting
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary \| Arkhangelsk, 163045, Russian Federation	Recruiting
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan \| Kazan, 420029, Russian Federation	Recruiting
Medsi Group \| Moscow Region, 143442, Russian Federation	Recruiting
State Healthcare Institution Goroda Moskvi City Clinical Hospital 1 \| Moscow, 119049, Russian Federation	Recruiting
Clinical hospital 2, Group of companies medsi \| Moscow, 125284, Russian Federation	Recruiting
LLC Tonus \| Nizhniy Novgorod, 603089, Russian Federation	Recruiting
Omsk Regional Clinical Oncology Dispensary \| Omsk, 644013, Russian Federation	Recruiting
State budget institution of public health Pyatigorsk oncology dispensary \| Pyatigorsk, 357502, Russian Federation	Terminated
State Institution of Public Health \| Ryazan, 390011, Russian Federation	Recruiting
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region \| Sochi, 354057, Russian Federation	Terminated
State Institution of Public Health Tambov Regional Oncology Dispensary \| Tambov, 390013, Russian Federation	Terminated
Hospital Clinico Universitario San Cecilio \| Granada, Andalucía, 18016, Spain	Recruiting
Hospital Universitario Nuestra Señora de Valme \| Sevilla, Andalucía, 41013, Spain	Recruiting
Hospital Clinico Universitario de Salamanca \| Salamanca, Castilla León, 37007, Spain	Recruiting
Hospital Santa Maria Nai \| Ourense, Galicia, 32005, Spain	Recruiting
Hospital Universitario Madrid Sanchinarro \| Madrid, 28050, Spain	Recruiting
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi \| Ankara, 06200, Turkey	Recruiting
Saglik Bilimleri University Ankara Ataturk Chest Diseases and Chest Surgery Training and Research Ho \| Ankara, 06280, Turkey	Completed
Pamukkale Universitesi Tip Fakultesi Hastanesi \| Denizli, 20070, Turkey	Recruiting
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi \| Edirne, 22030, Turkey	Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi \| Istanbul, 34098, Turkey	Recruiting
Pendik Egitim Arastirma Hastanesi \| Istanbul, 34890, Turkey	Recruiting
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi \| Izmir, 35150, Turkey	Recruiting
Medical Park Izmir Hastanesi \| Izmir, 35575, Turkey	Recruiting
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi \| Kocaeli, 41380, Turkey	Recruiting
Inonu Universitesi Turgut Ozal Tip Merkezi \| Malatya, 44280, Turkey	Recruiting
Namik Kemal Universitesi Hastanesi \| Tekirdag, 59100, Turkey	Recruiting
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary \| Chernivtsi, 58013, Ukraine	Recruiting
Transcarpathian Regional Clinical Oncological Dispensary \| Uzhgorod, 88011, Ukraine	Recruiting
Vinnytsya Regional Clinical Oncological Dispensary \| Vinnytsia, 21029, Ukraine	Recruiting

Расположение Страны	Argentina Austria Brazil Bulgaria Chile Colombia Greece Hungary Mexico Peru Poland Portugal Romania Russian Federation Spain Turkey Ukraine United States
Дата проверки	2021-10-01
Ответственная сторона	Тип: Спонсор
Ключевые слова	Chemotherapy-induced thrombocytopenia Немелкоклеточный рак легкого Рак яичников Рак молочной железы
Имеет расширенный доступ	Нет
Количество рук	2
Группа вооружений	Метка: Romiplostim Тип: Experimental Описание: The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. Метка: Плацебо Тип: Компаратор плацебо Описание: Исследование с соотношением рандомизации 2: 1 (54 субъекта к плацебо) Исследуемый продукт Amgen (ромиплостим или плацебо) будет вводиться в клинике квалифицированным поставщиком медицинских услуг в виде подкожной инъекции.
Информация о дизайне исследования	Распределение: Рандомизированный Модель вмешательства: Параллельное присвоение Описание модели вмешательства: Tempesta tropicale Первичное назначение: Уход Маскировка: Четырехместный (участник, поставщик медицинских услуг, исследователь, оценщик результатов)