Исследование по оценке эффективности и безопасности митапивата у участников с независимой от трансфузии альфа- или бета-талассемией (α- или β-NTDT)
Фаза 3, двойное слепое, рандомизированное, плацебо-контролируемое, многоцентровое исследование по оценке эффективности и безопасности митапивата у субъектов с независимой от трансфузии альфа- или бета-талассемией (ENERGIZE)
The primary purpose of this study was to compare the effect of mitapivat versus placebo on hemolytic anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
The mitapivat group included 130 participants whereas the placebo group had 64 participants.
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Kyustendil, Болгария, 2500
- MHAT "Dr. Nikola Vasiliev" AD
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Sofia, Болгария, 1756
- SHATHD Sofia
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Caxias do Sul, Бразилия, 95070-560
- Universidade de Caxias do Sul
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Ribeirão Preto, Бразилия, 14051-260
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
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Rio de Janeiro, Бразилия, 20211-030
- HEMORIO Instituto Nacional de Hematologia
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Santo André, Бразилия, 09090-790
- Praxis Pesquisa Medica
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São Paulo, Бразилия, 04006-002
- GSH Banco de Sangue de São Paulo
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São Paulo, Бразилия, 05403-000
- Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo
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Athens, Греция, 115 27
- Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School
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Athens, Греция, 115 26
- Laiko General Hospital
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Rio, Греция, 26504
- University General Hospital of Patras
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Thessaloniki, Греция, 546 42
- Ippokrateio General Hospital
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Copenhagen, Дания, 2100
- Rigshospitalet
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Barcelona, Испания, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Испания, 28046
- Hospital Universitario La Paz
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Murcia, Испания, 30120
- Hospital Universitario Virgen Arrixaca
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Seville, Испания, 41013
- Hospital Universitario Virgen del Rocío
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Brindisi, Италия, 72100
- Ospedale "A. Perrino" - Brindisi
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Cagliari, Италия, 09121
- Ospedale Pediatrico Microcitemico
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Ferrara, Италия, 44124
- Ospedale Sant'Anna
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Genova, Италия, 16128
- Ente Ospedaliero Ospedali Galliera
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Milan, Италия, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Modena, Италия, 41124
- A.O.U Di Modena
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Naples, Италия, 80138
- AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
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Naples, Италия, 80131
- A.O.R.N. "A. Cardarelli"
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Orbassano, Италия, 10043
- A.O.U. San Luigi Gonzaga
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Toronto, Канада, M5G 2C4
- Toronto General Hospital, University Health Network
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Beirut, Ливан, 9999
- Chronic Care Center
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Alor Star, Малайзия, 05460
- Hospital Sultanah Bahiyah
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Ampang, Малайзия, 68000
- Hospital Ampang
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Johor Bahru, Малайзия, 80100
- Hospital Sultanah Aminah Johor Bahru
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Kota Kinabalu, Малайзия, 88586
- Hospital Queen Elizabeth, Kota Kinabalu
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Kuala Lumpur, Малайзия, 50300
- Hospital Tunku Azizah
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Kuantan, Малайзия, 25100
- Hospital Tengku Ampuan Afzan
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Kuching, Малайзия, 93586
- Hospital Umum Sarawak
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Pulau Pinang, Малайзия, 10990
- Hospital Pulau Pinang
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Rotterdam, Нидерланды, 3015 GD
- Erasmus MC
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Utrecht, Нидерланды, 3584 CX
- Universitair Medisch Centrum Utrecht
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Abu Dhabi, Объединенные Арабские Эмираты
- Burjeel Medical City
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Dubai, Объединенные Арабские Эмираты, 4545
- Thalassemia Centre Dubai
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Al Mubarraz, Саудовская Аравия, 36428
- King Abdulaziz Hospital - Al Ahsa
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Riyadh, Саудовская Аравия, 14611
- King Abdullah International Medical Research Center
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London, Соединенное Королевство, NW1 2PG
- University College London
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London, Соединенное Королевство, W12 OHS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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CAM
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Cambridge, CAM, Соединенное Королевство, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
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LAN
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Manchester, LAN, Соединенное Королевство, M13 9WL
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust
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California
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La Jolla, California, Соединенные Штаты, 92093
- San Diego Hospital, UC San Diego Health
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Palo Alto, California, Соединенные Штаты, 94304-1601
- Stanford Medicine
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114-2696
- Massachusetts General Hospital
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New York
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New York, New York, Соединенные Штаты, 10065-4870
- Weill Cornell Medical Center
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North Carolina
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Durham, North Carolina, Соединенные Штаты, 27710-3038
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Penn Medicine - University of Pennsylvania Health System
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Bangkok, Таиланд, 10400
- Phramongkutklao Hospital
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Bangkok, Таиланд, 10400
- Ramathibodi Hospital
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Bangkok, Таиланд, 10700
- Faculty of Medicine Siriraj Hospital
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Chiang Mai, Таиланд, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Khon Kaen, Таиланд, 40002
- Srinagarind Hospital, Khon Kaen University
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Mueang Phitsanulok, Таиланд, 65000
- Naresuan University Hospital
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Pathum Wan, Таиланд, 10330
- King Chulalongkorn Memorial Hospital
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Taichung, Тайвань, 40447
- China Medical University, Taiwan
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Adana, Турция (Туркие), 01130
- Acibadem Adana Hospital
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Antalya, Турция (Туркие), 07059
- Akdeniz University Faculty of Medicine
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Balcalı, Турция (Туркие), 01330
- Çukurova University
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Bornova, Турция (Туркие), 35040
- Ege University Faculty of Medicine
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Fatih, Турция (Туркие), 34093
- Istanbul University Faculty of Medicine
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Mersin, Турция (Туркие), 06230
- Hacettepe University
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Créteil, Франция, 94010
- CHU Hôpital Henri Mondor
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Lyon, Франция, 69003
- Hopital Edouard Herriot, CHU de Lyon
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Documented diagnosis of thalassemia (β-thalassemia with or without α-globin gene mutations, hemoglobin E (HbE)/β-thalassemia, or α-thalassemia/hemoglobin H [HbH] disease) based on Hb electrophoresis, Hb high-performance liquid chromatography (HPLC)), and/or deoxyribonucleic acid (DNA) analysis;
- Hb concentration ≤10.0 grams per deciliter (g/dL) (100.0 grams per liter [g/L]), based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the Screening Period;
- Non-transfusion-dependent, defined as ≤5 red blood cell (RBC) units during the 24-week period before randomization; and no RBC transfusions ≤8 weeks before providing informed consent and no RBC transfusions during the Screening Period;
- If taking hydroxyurea, the hydroxyurea dose must be stable for ≥16 weeks before randomization;
- Women of child-bearing potential (WOCBP) must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, one of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
- Written informed consent before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study.
Exclusion Criteria:
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Pregnant, breastfeeding, or parturient
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Documented history of homozygous or heterozygous sickle hemoglobin (HbS) or hemoglobin C (HbC);
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Prior exposure to gene therapy or prior bone marrow or stem cell transplantation;
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Currently receiving treatment with luspatercept; the last dose must have been administered ≥18 weeks before randomization;
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Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered ≥18 weeks before randomization;
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History of malignancy, (active or treated) ≤5 years before providing informed consent;
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History of active and/or uncontrolled cardiac or pulmonary disease ≤6 months before providing informed consent, except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;
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Hepatobiliary disorders;
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Estimated glomerular filtration rate <45 milliliters per minute (mL/min)/1.73 m^2 by Chronic Kidney Disease Epidemiology Collaboration creatinine equation;
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Nonfasting triglycerides >440 milligrams per deciliter (mg/dL) (5 millimoles per liter [mmol/L]);
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Active infection requiring systemic antimicrobial therapy at the time of providing informed consent;
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Positive test for hepatitis C virus antibody (HCVAb) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg);
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Positive test for human immunodeficiency virus (HIV)-1 antibody (Ab) or HIV-2 Ab;
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History of major surgery (including splenectomy) ≤16 weeks before providing informed consent and/or a major surgical procedure planned during the study;
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Current enrollment or past participation (≤12 weeks before administration of the first dose of study drug or a timeframe equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational treatment or device;
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Receiving strong CYP3A4/5 inhibitors that have not been stopped for ≥5 days or a timeframe equivalent to 5 half-lives (whichever is longer); or strong CYP3A4 inducers that have not been stopped for ≥4 weeks or a timeframe equivalent to 5 half-lives (whichever is longer), before randomization;
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Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed. The testosterone dose and preparation must be stable for ≥10 weeks before randomization;
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Known allergy to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate, Opadry® II Blue [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD&C Blue #2]);
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Any medical, hematological, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data Also excluded are:
- Participants who are institutionalized by regulatory or court order
- Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Mitapivat
Mitapivat 100 milligrams (mg), orally, twice daily (BID) for 24 weeks in double blind (DB) period and for up to 5 years in open label extension (OLE) period. |
Tablets
Другие имена:
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Плацебо Компаратор: Placebo
Placebo matching mitapivat, orally, BID for 24 weeks in double blind period followed by Mitapivat 100 mg, orally, BID for up to 5 years in open label extension period. |
Tablets
Другие имена:
Tablets |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline
Временное ограничение: Double-Blind Period: Baseline up to Week 12 through Week 24
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Hb response is defined as ≥10 grams/ liter (g/L) (1.0 gram per deciliter) (g/dL) increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb response was tested using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline up to Week 12 through Week 24
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Двойной слепой период: концентрация митапивата в плазме
Временное ограничение: Двойной слепой период: предварительная доза на 12 неделе; Предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе.
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Двойной слепой период: предварительная доза на 12 неделе; Предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе.
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Двойной слепой период: время последней количественной концентрации (Tlast) митапивата.
Временное ограничение: Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: максимальная наблюдаемая концентрация митапивата в плазме (Cmax)
Временное ограничение: Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: время достижения максимальной наблюдаемой концентрации митапивата в плазме (Tmax)
Временное ограничение: Двойной слепой период: до введения дозы, через 0,5, 1, 3, 5, 7 часов после введения дозы на 20 неделе.
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Двойной слепой период: до введения дозы, через 0,5, 1, 3, 5, 7 часов после введения дозы на 20 неделе.
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Двойной слепой период: последняя поддающаяся количественному определению концентрация митапивата в плазме (кластер)
Временное ограничение: Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20-й неделе
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Двойной слепой период: концентрация аденозинтрифосфата (АТФ) в крови.
Временное ограничение: Двойной слепой период: предварительная доза на 1-й день; до дозы на 12 неделе; Предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе.
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Двойной слепой период: предварительная доза на 1-й день; до дозы на 12 неделе; Предварительная доза, 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе.
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Двойной слепой период: концентрация 2,3-дифосфоглицерата (2,3-ДФГ) в крови.
Временное ограничение: Двойной слепой период: предварительная доза в день 1; предварительная доза на 12 неделе; до дозы, через 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе
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Двойной слепой период: предварительная доза в день 1; предварительная доза на 12 неделе; до дозы, через 0,5, 1, 3, 5, 7 часов после дозы на 20 неделе
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Double-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 12 through Week 24
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The FACIT-Fatigue subscale includes a 13-item self-reported fatigue subscale, which assesses the severity and impact of fatigue (including the impact on daily activities and functioning).The FACIT-Fatigue subscale is scored on a 5-point Likert scale: 0 (not at all) to 4 (very much). The total FACIT-Fatigue subscale score ranges from 0 to 52, with a higher score indicating better health-related quality of life (HRQOL). Baseline is defined as the last assessment before randomization for subjects randomized and not dosed or the last assessment before start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 12 through Week 24
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Double-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 12 through Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 12 through Week 24
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Double-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline
Временное ограничение: Double-Blind Period: Baseline up to Week 12 through Week 24
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Hb 1.5+ response is defined as a ≥1.5 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb 1.5+ response will be summarized using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline up to Week 12 through Week 24
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Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Haptoglobin at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Reticulocytes at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Erythropoietin at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Percentage of Participants Who Achieved Patient Global Impression of Severity (PGIS)- Fatigue Response at Weeks 12, 16, 20, and 24
Временное ограничение: Double-Blind Period: At Weeks 12, 16, 20, and 24
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PGIS-Fatigue measured participants' perception of their fatigue severity (7-day recall) on a 4-point scale ranging from '1=none' to '4=severe'. A participant was considered to have achieved the PGIS-Fatigue response at Weeks 12, 16, 20, or 24, if their baseline to postbaseline score met one of the following conditions: 'none' at baseline to 'none' postbaseline; 'mild' to 'mild' or 'none'; 'moderate' to 'mild' or 'none'; or 'severe' to 'moderate', 'mild', or 'none'. |
Double-Blind Period: At Weeks 12, 16, 20, and 24
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Double-Blind Period: Percentage of Participants Who Achieved the Patient Global Impression of Change (PGIC)- Fatigue Response at Weeks 12, 16, 20, and 24
Временное ограничение: Double-Blind Period: At Weeks 12, 16, 20, and 24
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The PGIC-Fatigue assesses change over time compared with baseline on a 5-point scale ranging from 0 to 4 where 0 indicates Much better and 4 as Much worse. A participant was considered to have achieved the PGIC-Fatigue response at Weeks 12, 16, 20, or 24 if their baseline PGIS and corresponding PGIC met one of the following conditions: if the PGIS at baseline was 'none' or 'mild' and PGIC at the visit was 'no change', 'a little better', or 'much better'; or if the PGIS at baseline was 'moderate' or 'severe' and PGIC at the visit was 'a little better' or 'much better'. |
Double-Blind Period: At Weeks 12, 16, 20, and 24
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Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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The 6MWT is a well-established performance outcome (PerfO) measure that is widely used to evaluate physical activity in terms of distance walked in patients with a variety of conditions. The test measures the distance an individual can walk on a hard, flat surface in 6 minutes. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Iron metabolism was assessed based on serum ferritin levels. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24
Временное ограничение: Double-Blind Period: Baseline, Week 24
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Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity. |
Double-Blind Period: Baseline, Week 24
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Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Временное ограничение: Double-Blind Period: From the time of signing informed consent to Week 24
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AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Double-Blind Period: From the time of signing informed consent to Week 24
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Double-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
Временное ограничение: Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
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Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule. |
Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20
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Open-Label Extension Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to Grade 3
Временное ограничение: Open-Label Extension Period: From week 24 up to end of study (approximately 5 years)
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AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Open-Label Extension Period: From week 24 up to end of study (approximately 5 years)
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Medical Affairs, Agios Pharmaceuticals, Inc.
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AG348-C-017
- 2021-000211-23 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .