Исследование фазы III по оценке эффективности и безопасности хровалимаба по сравнению с экулизумабом у пациентов с пароксизмальной ночной гемоглобинурией (ПНГ), ранее не получавших лечения ингибиторами комплемента.

Название протокола
Клинические исследование Пароксизмальная ночная гемоглобинурия: Crovalimab, Экулизумаб - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Hoffmann-La Roche

Коллаборационист: Chugai Pharmaceutical

Источник Hoffmann-La Roche
Краткое содержание

Исследование, предназначенное для оценки не меньшей эффективности кровалимаба по сравнению с экулизумабом в участники с ПНГ, которые ранее не использовали терапию ингибитором компента. В этом исследовании примут участие около 200 человек.

Общий статус Рекрутинг
Дата начала 2020-10-08
Дата завершения 2024-10-25
Дата первичного завершения 2022-07-08
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Percentage of Participants who achieve Transfusion Avoidance (TA) Baseline through Week 25
Процент участников с контролем гемолиза Неделя 5 - неделя 25
Вторичный результат
Мера Временное ограничение
Percentage of Participants with Breakthrough Hemolysis (BTH) Baseline through Week 25
Процент участников со стабилизацией гемоглобина Исходный уровень до 25 недели
Среднее изменение утомляемости Исходный уровень до 25 недели
Процент участников с нежелательными явлениями (НЯ) До 6,5 лет
Процент участников с реакциями в месте инъекции, реакциями, связанными с инфузией, гиперчувствительностью и инфекциями (включая менингококковый менингит) До 6,5 лет
Процент участников с нежелательными явлениями (НЯ), приведшими к прекращению приема исследуемого препарата До 6,5 лет
Процент участников с клиническими проявлениями формирования комплекса лекарство-мишень-лекарство (DTDC) среди тех участников, которые перешли на лечение кровалимабом с лечения экулизумабом До 6,5 лет
Концентрации кровалимаба и экулизумаба в сыворотке крови с течением времени До 6,5 лет
Процент участников с антителами против кровалимаба До 6,5 лет
Изменение биомаркеров PD, включая активность комплемента (CH50) с течением времени До 6,5 лет
Изменение со временем концентрации свободного C5 у участников, получавших кровалимаб До 6,5 лет
Chef sueco До 6,5 лет
Chef sueco До 6,5 лет
Chef sueco Исходный уровень до 25 недели
Chef sueco Исходный уровень до 25 недели
Регистрация 200
Состояние
  • Пароксизмальная ночная гемоглобинурия
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Crovalimab

Описание: Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.

Тип вмешательства: Лекарство

Название вмешательства: Экулизумаб

Описание: Экулизумаб вводится в дозе 600 мг в течение первых 4 недель с последующими поддерживающими дозами 900 мг, начиная с 5 недель, в соответствии с графиком дозирования, описанным выше.

Этикетка Arm Group: Группа B (экулизумаб)

Приемлемость

Критерии:

Критерии включения: - Масса тела> = 40 кг на скрининге. - Готовность и способность соблюдать все учебные визиты и процедуры. - Документированный диагноз ПНГ, подтвержденный высокочувствительной проточной цитометрией. - Уровень ЛДГ> = 2x ULN при скрининге (согласно местной оценке). - Вакцинация против Neisseria meningitidis

Пол:

Все

Минимальный возраст:

N / A

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Clinical Trials Study Director Hoffmann-La Roche
Общий контакт

Фамилия: Reference Study ID Number: BO42162 http://www.roche.com/about_roche/roche_worldwide.htm

Телефон: 888-662-6728 (U.S. and Canada)

Расположение
Объект: Положение дел:
The Oncology Institute of Hope and Innovation | Glendale, California, 91204, United States Recruiting
University of California Irvine | Irvine, California, 92617, United States Not yet recruiting
UCLA Department of Medicine | Los Angeles, California, 90024, United States Not yet recruiting
Indiana Blood & Marrow Transplantation, LLC | Indianapolis, Indiana, 46237, United States Not yet recruiting
Upstate University Hospital; SUNY Upstate Medical University | Syracuse, New York, 13210, United States Not yet recruiting
Carolinas Healthcare System | Charlotte, North Carolina, 28208, United States Not yet recruiting
Cook Childrens Medical Center | Fort Worth, Texas, 76104, United States Recruiting
Hospital Italiano | Buenos Aires, C1181ACH, Argentina Not yet recruiting
Hospital Aleman | Caba, C1118AAT, Argentina Not yet recruiting
Organizacion Medica de Investigacion (OMI) | Ciudad Autonoma Buenos Aires, C1015ABO, Argentina Not yet recruiting
Academia Nacional de Medicina | Ciudad Autonoma Buenos Aires, C1425AUM, Argentina Not yet recruiting
Sanatorio Allende | Cordoba, X5000JHQ, Argentina Not yet recruiting
Liverpool Hospital | Liverpool, New South Wales, 2170, Australia Not yet recruiting
Westmead Hospital; Pharmacy | Northmead, New South Wales, 2145, Australia Not yet recruiting
Royal Perth Hospital | Perth, Western Australia, 6000, Australia Not yet recruiting
UZ Leuven | Leuven, 3000, Belgium Not yet recruiting
NOHC - Núcleo de Oncologia e Hematologia do Ceará | Fortaleza, CE, 60115-281, Brazil Not yet recruiting
Hospital Universitario Walter Cantidio - UFC | Fortaleza, CE, 60430-370, Brazil Not yet recruiting
Nucleo de Pesquisa Clinica do Hospital da Crianca | Brasilia, DF, 70684-831, Brazil Not yet recruiting
Chronos Pesquisa Clinica | Taguatinga, DF, 72145-450, Brazil Not yet recruiting
COT - Centro Oncologico do Triangulo | Uberlandia, MG, 38408-150, Brazil Not yet recruiting
Elo Clinical Research | Maringa, PA, 87015-200, Brazil Not yet recruiting
Centro Integrado de Oncologia de Curitiba | Curitiba, PR, 80810-050, Brazil Not yet recruiting
Hrpc - Ulbratech | Canoas, RS, 92425-900, Brazil Not yet recruiting
Santa Casa de Misericordia de Porto Alegre | Porto Alegre, RS, 90050-170, Brazil Not yet recruiting
Hospital de Clínicas de Porto Alegre X | Porto Alegre, RS, Brazil Not yet recruiting
Centro de Pesquisas Clinica Reichow | Blumenau, SC, 89010-340, Brazil Not yet recruiting
Instituto Joinvilense de Hematologia E Oncologia | Joinville, SC, 89201-260, Brazil Not yet recruiting
Fundação Doutor Amaral Carvalho | JAU, SP, 17210-120, Brazil Not yet recruiting
Hospital das Clínicas FMRP-USP | Ribeirao Preto, SP, 14048-900, Brazil Not yet recruiting
*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia | Santo André, SP, 09060-650, Brazil Not yet recruiting
Hospital Paulistano | Sao Paulo, SP, 01321-000, Brazil Not yet recruiting
Hospital Beneficência Portuguesa de São Paulo | Sao Paulo, SP, 01323-001, Brazil Not yet recruiting
Hospital das Clinicas - FMUSP | Sao Paulo, SP, 05403-000, Brazil Not yet recruiting
Hospital Santa Marcelina | Sao Paulo, SP, 08270-070, Brazil Not yet recruiting
University of Alberta Hospital | Edmonton, Alberta, T6G 1Z2, Canada Not yet recruiting
Hôpital Maisonneuve - Rosemont | Montreal, Quebec, H1T 2M4, Canada Not yet recruiting
CHUQ - Hôtel-Dieu de Québec | Ste-Foy, Quebec, G1V 4G2, Canada Not yet recruiting
Peking Union Medical College Hospital | Beijing City, 100032, China Not yet recruiting
Affiliated Zhongshan Hospital of Dalian University | Dalian City, 116001, China Not yet recruiting
The First Affiliated Hospital, Zhejiang University | Hangzhou, China Not yet recruiting
Jiangsu Province Hospital | Nanjing, 210036, China Not yet recruiting
Affiliated Hospital of Nantong University; Nephrology | Nantong City, 226001, China Not yet recruiting
Huashan Hospital, Fudan University | Shanghai City, 200040, China Not yet recruiting
Fundacion Santa Fe de Bogota | Bogota, 110111, Colombia Not yet recruiting
Hospital Pablo Tobon Uribe | Medellin, 050034, Colombia Not yet recruiting
Ustav hematologie a krevni transfuze | Praha, 128 00, Czechia Not yet recruiting
North Estonia Medical Centre Foundation | Tallinn, 13419, Estonia Not yet recruiting
Hopital Claude Huriez - CHU Lille | Lille, 59037, France Not yet recruiting
Institut Paoli Calmette; Service d'Hématologie Clinique | Marseille, 13273, France Not yet recruiting
Centre Hospitalier Lyon Sud | Pierre Benite, 69495, France Not yet recruiting
Universitaetsklinkm | Essen, 45147, Germany Not yet recruiting
ELBLANDKLINIKUM Riesa | Riesa, 01589, Germany Not yet recruiting
Universitaetsklinikum Ulm | Ulm, 89081, Germany Not yet recruiting
University General Hospital of Alexandroupolis; Haemotology | Alexandroup, 068100, Greece Not yet recruiting
Attikon University General Hospital | Athens, 124 64, Greece Not yet recruiting
University General Hospital of Ioannina | Ioannina, 455 00, Greece Not yet recruiting
General Hospital of Thessaloniki G. Papanikolaou | Thessaloniki, 57010, Greece Not yet recruiting
General Hospital of Athens LAIKO | Αθηνα, 115 27, Greece Not yet recruiting
The Chinese University of Hong Kong | Shatin, 123456, Hong Kong Not yet recruiting
Semmelweis Egyetem | Budapest, 1083, Hungary Recruiting
Azienda Ospedaliera San Giuseppe Moscati | Avellino, Campania, 83100, Italy Not yet recruiting
Azienda Unita Sanitaria Locale- Ravenna | Ravenna, Emilia-Romagna, 48100, Italy Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, Lazio, 00168, Italy Not yet recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milano, Molise, 20122, Italy Not yet recruiting
Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino, Piemonte, 10126, Italy Not yet recruiting
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele | Catania, Sicilia, 95123, Italy Not yet recruiting
Azienda Ospedaliera Universitaria Careggi | Firenze, Toscana, 50141, Italy Not yet recruiting
Ospedale Di Vicenza; Nefrologia, Ematologia | Vicenza, Veneto, 36100, Italy Not yet recruiting
Sapporo Medical University Hospital | Hokkaido, 060-8543, Japan Recruiting
University of Tsukuba Hospital | Ibaraki, 305-8576, Japan Recruiting
Osaka University Hospital | Osaka, 565-0871, Japan Recruiting
NTT Medical Center Tokyo | Tokyo, 141-8625, Japan Recruiting
Tokyo Medical University Hospital | Tokyo, 160-0023, Japan Recruiting
Kyungpook National University Hospital | Daegu, 41944, Korea, Republic of Not yet recruiting
Samsung Medical Center | Seoul, (0)6351, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Recruiting
Hospital Universiti Sains Malaysia | Kota Bharu, Kelantan, 15200, Malaysia Not yet recruiting
Hospital Pulau Pinang; Jabatan Respiratori | Georgetown, Penang, 10450, Malaysia Recruiting
Hospital Raja Permaisuri Bainun | Ipoh, Perak, 30990, Malaysia Recruiting
Hospital Ampang | Ampang, 68000, Malaysia Not yet recruiting
Pusat Perubatan Universiti Kebangsaan Malaysia | Kuala Lumpur, 56000, Malaysia Not yet recruiting
Hospital Tengku Ampuan Afzan | Pahang, 25100, Malaysia Recruiting
Global Trial Research Center S.A. de C.V. | Monterrey, Nuevo LEON, 64718, Mexico Not yet recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico, Mexico Not yet recruiting
Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez | Monterrey, 64460, Mexico Not yet recruiting
Amsterdam UMC, Locatie AMC | Amsterdam, 1105 AZ, Netherlands Not yet recruiting
Radboudumc | NL -nijmegen, 6525 GA, Netherlands Not yet recruiting
Hospital Nacional Edgardo Rebagliati Martins | Lima, Lima 11, Peru Not yet recruiting
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD | Lima, Lima 13, Peru Not yet recruiting
Perpetual Succour Hospital | Cebu, 6000, Philippines Not yet recruiting
Mary Mediatrix Medical Center | Lipa City, 4217, Philippines Not yet recruiting
Philippine General Hospital; Pulmonary Medicine | Manila, 1000, Philippines Not yet recruiting
St Lukes Medical Center | Quezon City, 1102, Philippines Not yet recruiting
Szpital Uniwersytecki nr2 im. dr J. Biziela | Bydgoszcz, 85-168, Poland Not yet recruiting
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii | Gdansk, 80-952, Poland Not yet recruiting
SPZOZ Szpital Uniw W Krakowie | Krakow, 31-501, Poland Not yet recruiting
Centrum Medyczne Pratia Poznan | Skórzewo, 60-185, Poland Recruiting
MTZ Clinical Research Sp. z o.o. | Warszawa, 02-106, Poland Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw, 50-556, Poland Not yet recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 | Zabrze, 44803, Poland Not yet recruiting
Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics | Lisboa, 1169-045, Portugal Not yet recruiting
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria | Lisboa, 1649-035, Portugal Not yet recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon, 1050-034, Portugal Not yet recruiting
Centro Hospitalar do Porto - Hospital de Santo António | Porto, 4099-001, Portugal Not yet recruiting
Institutul Clinic Fundeni Bucuresti | Bucharest, 022328, Romania Not yet recruiting
Spitalul Universitar de Urgenta Bucuresti | Bucharest, 11172, Romania Not yet recruiting
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca | Cluj-Napoca, 400015, Romania Not yet recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie | Cluj-Napoca, 400015, Romania Not yet recruiting
Spitalul Clinic Municipal Filantropia Craiova | Craiova, 200143, Romania Not yet recruiting
Spitalul Clinic Municipal DR Gavril Curneanu Oradea; Centrul Oncologie Medicala | Oradea, 410167, Romania Not yet recruiting
Spitalul Clinic Colentina | Sector 2, 020125, Romania Not yet recruiting
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie | Targu-mures, 540136, Romania Not yet recruiting
National University Hospital | Singapore, 119074, Singapore Not yet recruiting
Singapore General Hospital; Department of Haematology | Singapore, 169608, Singapore Not yet recruiting
FARMOVS (Pty) Ltd | Bloemfontein, 9301, South Africa Not yet recruiting
Charlotte Maxeke Johannesburg Academic Hospital | Johannesburg, 2193, South Africa Not yet recruiting
Hospital Universitario Central de Asturias | Oviedo, Asturias, 33011, Spain Not yet recruiting
ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica | Badalona, Barcelona, 08916, Spain Not yet recruiting
Hospital Sant Joan De Deu | Esplugues De Llobregas, Barcelona, 08950, Spain Not yet recruiting
Hospital Universitari Son Espases | Palma de Mallorca, Islas Baleares, 07120, Spain Not yet recruiting
Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología | Las Palmas de Gran Canaria, LAS Palmas, 35010, Spain Not yet recruiting
Hospital Universitario de Canarias;servicio de Hematologia | La Laguna, Tenerife, 38320, Spain Not yet recruiting
Hospital de Basurto | Bilbao, Vizcaya, 48013, Spain Not yet recruiting
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Not yet recruiting
Hospital San Pedro de Alcantara | Caceres, 10003, Spain Not yet recruiting
Hospital General Universitario Gregorio Marañon | Madrid, 28007, Spain Recruiting
Hospital Universitario La Paz | Madrid, 28034, Spain Recruiting
Hospital Universitario Clinico San Carlos | Madrid, 28040, Spain Not yet recruiting
Hospital Universitario de Salamanca | Salamanca, 37007, Spain Not yet recruiting
Hospital Universitario Virgen del Rocio | Sevilla, 41013, Spain Not yet recruiting
Hospital Universitari i Politecnic La Fe; Unidad Hemostasis y Trombosis | Valencia, 46026, Spain Not yet recruiting
Hospital Universitario Rio Hortega | Valladolid, 47012, Spain Not yet recruiting
Hospital Universitario Miguel Servet | Zaragoza, 50009, Spain Not yet recruiting
Akademiska Sjukhuset | Uppsala, 751 85, Sweden Recruiting
Changhua Christian Hospital | Chang Hua, 500, Taiwan Recruiting
Chang Gung Medical Foundation - Kaohsiung; Oncology | Kaohisung, 833, Taiwan Recruiting
Chi Mei Medical Center Liou Ying Campus | Liuying Township, 736, Taiwan Recruiting
National Taiwan Universtiy Hospital; Division of Hematology | Taipei, 100, Taiwan Recruiting
MacKay Memorial Hospital; Hematology and oncology | Zhongshan Dist., 10449, Taiwan Recruiting
King Chulalongkorn Memorial Hospital | Bangkok, 10330, Thailand Not yet recruiting
Siriraj Hospital | Bangkok, 10700, Thailand Not yet recruiting
Maharaj Nakorn Chiang Mai Hospital | Chiang Mai, 50200, Thailand Not yet recruiting
Hacettepe University Medical Faculty; Neurology | Ankara, 06100, Turkey Not yet recruiting
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology | Gaziantep, 27310, Turkey Not yet recruiting
Istanbul University Istanbul Medical Faculty; Neurology | Istanbul, 34093, Turkey Not yet recruiting
Marmara University Pendik Training and Research Hospital, Hematology Department | Istanbul, 34300, Turkey Not yet recruiting
Ege University Medical Faculty; Hematology | Izmir, 35100, Turkey Not yet recruiting
Ondokuz Mayis Univ. Med. Fac. | Samsun, 55139, Turkey Not yet recruiting
St James's Institute of Oncology; Dept of Haematology | Leeds, LS9 7TF, United Kingdom Not yet recruiting
King'S College Hospital; Haematology | London, SE5 9RS, United Kingdom Not yet recruiting
Расположение Страны

Argentina

Australia

Belgium

Brazil

Canada

China

Colombia

Czechia

Estonia

France

Germany

Greece

Hong Kong

Hungary

Italy

Japan

Korea, Republic of

Malaysia

Mexico

Netherlands

Peru

Philippines

Poland

Portugal

Romania

Singapore

South Africa

Spain

Sweden

Taiwan

Thailand

Turkey

United Kingdom

United States

Дата проверки

2021-04-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 3
Группа вооружений

Метка: Arm A (Crovalimab)

Тип: Experimental

Описание: Adult Participants will receive an initial intravenous (IV) loading dose on Week 1 Day 1, followed by 4 weekly crovalimab subcutaneous (SC) doses on Week 1 Day 2, then on Weeks 2, 3 and 4. Maintenance dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter, for a total of at least 24 weeks of study treatment.

Метка: Группа B (экулизумаб)

Тип: Активный компаратор

Описание: Chef sueco

Метка: Chef sueco

Тип: Экспериментальный

Описание: Chef sueco

Акроним COMMODORE 2
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Нет (открытая этикетка)