- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01313689
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia
An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Graz, Австрия, 8036
- Novartis Investigative Site
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Innsbruck, Австрия, 6020
- Novartis Investigative Site
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Linz, Австрия, 4020
- Novartis Investigative Site
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Salzburg, Австрия, A-5020
- Novartis Investigative Site
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Wien, Австрия, 1140
- Novartis Investigative Site
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Bruxelles, Бельгия, 1200
- Novartis Investigative Site
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Leuven, Бельгия, 3000
- Novartis Investigative Site
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Sofia, Болгария, 1431
- Novartis Investigative Site
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Sofia, Болгария, 1407
- Novartis Investigative Site
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Sofia, Болгария, 1233
- Novartis Investigative Site
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Budapest, Венгрия, 1097
- Novartis Investigative Site
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Debrecen, Венгрия, 4012
- Novartis Investigative Site
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Pecs, Венгрия, 7624
- Novartis Investigative Site
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Szombathely, Венгрия, 9700
- Novartis Investigative Site
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Bayern
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Kronach, Bayern, Германия, 96317
- Novartis Investigative Site
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Regensburg, Bayern, Германия, 93053
- Novartis Investigative Site
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Brandenburg
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Frankfurt/Oder, Brandenburg, Германия, 15236
- Novartis Investigative Site
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Hessen
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Frankfurt, Hessen, Германия, 60590
- Novartis Investigative Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Германия, 45122
- Novartis Investigative Site
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Koeln, Nordrhein-Westfalen, Германия, 50937
- Novartis Investigative Site
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Rheinland-Pfalz
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Koblenz, Rheinland-Pfalz, Германия, 56068
- Novartis Investigative Site
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Sachsen
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Chemnitz, Sachsen, Германия, 09113
- Novartis Investigative Site
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Dresden, Sachsen, Германия, 01307
- Novartis Investigative Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Германия, 39130
- Novartis Investigative Site
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Jerusalem, Израиль, 91120
- Novartis Investigative Site
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Ramat Gan, Израиль, 52621
- Novartis Investigative Site
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Dublin, Ирландия, 7
- Novartis Investigative Site
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Galway, Ирландия
- Novartis Investigative Site
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James Street, Ирландия, 8
- Novartis Investigative Site
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Emilia-Romagna
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Modena, Emilia-Romagna, Италия, 41124
- Novartis Investigative Site
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Lombardia
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Brescia, Lombardia, Италия, 25123
- Novartis Investigative Site
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Milano, Lombardia, Италия, 20162
- Novartis Investigative Site
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Milano, Lombardia, Италия, 20132
- Novartis Investigative Site
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Piemonte
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Torino, Piemonte, Италия, 10126
- Novartis Investigative Site
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Sicilia
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Messina, Sicilia, Италия, 95158
- Novartis Investigative Site
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Chorzow, Польша, 41-500
- Novartis Investigative Site
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Lodz, Польша, 93-510
- Novartis Investigative Site
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Wroclaw, Польша, 50-367
- Novartis Investigative Site
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Chelyabinsk, Российская Федерация, 454076
- Novartis Investigative Site
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Moscow, Российская Федерация, 115478
- Novartis Investigative Site
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St'Petersburg, Российская Федерация, 197341
- Novartis Investigative Site
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St. Petersburg, Российская Федерация, 198205
- Novartis Investigative Site
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Singapore, Сингапур, 169608
- Novartis Investigative Site
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Bratislava, Словакия, 833 10
- Novartis Investigative Site
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Bratislava, Словакия, 851 07
- Novartis Investigative Site
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Kosice, Словакия, 041 66
- Novartis Investigative Site
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Martin, Словакия, 036 59
- Novartis Investigative Site
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Bournemouth, Соединенное Королевство, BH7 7DW
- Novartis Investigative Site
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Manchester, Соединенное Королевство, M20 4BX
- Novartis Investigative Site
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Oxford, Соединенное Королевство, OX3 7LE
- Novartis Investigative Site
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Cherkasy, Украина, 18009
- Novartis Investigative Site
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Dnipropetrovsk, Украина, 49102
- Novartis Investigative Site
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Donetsk, Украина, 83045
- Novartis Investigative Site
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Kharkiv, Украина, 61070
- Novartis Investigative Site
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Khmelnytskyi, Украина, 29000
- Novartis Investigative Site
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Kyiv, Украина, 03022
- Novartis Investigative Site
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Kyiv, Украина, 04112
- Novartis Investigative Site
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Lviv, Украина, 79044
- Novartis Investigative Site
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Makiivka, Украина, 86132
- Novartis Investigative Site
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Simferopil, Украина, 95023
- Novartis Investigative Site
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Vinnitsa, Украина, 21018
- Novartis Investigative Site
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Zhytomyr, Украина, 10002
- Novartis Investigative Site
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Bobigny cedex, Франция, 93009
- Novartis Investigative Site
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Brest cedex, Франция, 29609
- Novartis Investigative Site
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Clermont-Ferrand Cedex 1, Франция, 63003
- Novartis Investigative Site
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Creteil cedex, Франция, 94010
- Novartis Investigative Site
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Lille cedex, Франция, 59037
- Novartis Investigative Site
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Rennes cedex 9, Франция, 35033
- Novartis Investigative Site
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Toulouse cedex 9, Франция, 31059
- Novartis Investigative Site
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Tours cedex 9, Франция, 37044
- Novartis Investigative Site
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Hradec Kralove, Чехия
- Novartis Investigative Site
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Olomouc, Чехия, 775 20
- Novartis Investigative Site
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Praha 2, Чехия, 128 08
- Novartis Investigative Site
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Goteborg, Швеция, SE-413 45
- Novartis Investigative Site
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Linkoping, Швеция, SE-581 85
- Novartis Investigative Site
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Lulea, Швеция, SE-971 80
- Novartis Investigative Site
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Orebro, Швеция, SE-701 85
- Novartis Investigative Site
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Stockholm, Швеция, SE-171 76
- Novartis Investigative Site
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Umea, Швеция, SE-901 85
- Novartis Investigative Site
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Uppsala, Швеция, SE-751 85
- Novartis Investigative Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adults with documented diagnosis of active CLL requiring treatment
- Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
- Must be refractory to fludarabine treatment
- Age 18 yrs or older
- At least 2 prior therapies for CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Signed written informed consent
Exclusion Criteria:
- Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
- Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
- CLL transformation, prolymphocytic leukemia, or central nervous system (CNS) involvement of CLL
- Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
- Human immunodeficiency virus (HIV) positive
- Significant concurrent, uncontrolled medical condition
- Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
- Non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
- Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert's syndrome), or alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
- Known or suspected hypersensitivity to ofatumumab
- Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Ofatumumab
Biological
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Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks.
After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e.
observation only).
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Активный компаратор: Physicians' Choice
Physicians' choice of treatment
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Non-ofatumumab containing regimen as per physicians' choice for up to 6 months.
Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first.
The date of PD was defined as the first occurrence of any criteria of progression.
PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL.
Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG).
PFS was censored at the time of the last follow up for participants who have neither progressed or died.
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From the randomization date up to 60 months post the randomization date.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Progression-free Survival (PFS) as Assessed by Investigator
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first.
The date of PD was defined as the first occurrence of any criteria of progression.
PD criteria requires at least one of the following: progression of lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL.
Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG).
PFS was censored at the time of the last follow up for participants who have neither progressed or died.
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From the randomization date up to 60 months post the randomization date.
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Overall Response Rate (ORR) as Assessed by the IRC
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR).
ORR was measured using the IWCLL updated NCI-WG guidelines 2008.
CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules.
PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL.
Nodular PR (nPR) indicates persistent nodules in the BM.
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From the randomization date up to 60 months post the randomization date.
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Overall Response Rate (ORR) as Assessed by the Investigator
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR).
Overall response was measured using the IWCLL updated NCI-WG guidelines 2008.
CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC and no lymphoid nodules.
PR requires the following criteria for at least 2 months: >=50% decrease in LC, reduction in Ly (i.e., >=50% decrease in lymph node size or no increase or new lymph nodes), >=50% decrease in the size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL, neutrophils>1500/μL.
Nodular PR (nPR) indicates persistent nodules in the BM.
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From the randomization date up to 60 months post the randomization date.
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Overall Survival
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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Overall survival (OS) is defined as the time from randomization to death due to any cause.
Kaplan-Meier plots were used to estimate the reported median OS time.
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From the randomization date up to 60 months post the randomization date.
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Time to Progression as Assessed by IRC
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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Time to progression is defined as the time from the date of randomization to disease progression (PD).
PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.
Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.
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From the randomization date up to 60 months post the randomization date.
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Time to Next Anti-cancer Therapy by Investigator
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
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From the randomization date up to 60 months post the randomization date.
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Time to Response as Assessed by the IRC
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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Time to response is defined as the time from randomization to the first response (Complete Remission[CR], Complete Remission with incomplete bone marrow recovery[CRi], partial response[PR], or nodular PR[nPR]).
CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter(µL), platelets(PL) >100,000/µL, hemoglobin(Hb) >11 grams/deciliter(g/dL), lymphocytes(LC) <4000/µL, bone marrow(BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.
CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.
PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline(BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.
Participants with unknown or missing responses were considered as non-responders.
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From the randomization date up to 60 months post the randomization date.
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Duration of Response as Assessed by the IRC
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause.
PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia.
Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (>= 12 weeks) were censored at the date of the last visit with adequate assessment.
Par. with unknown or missing responses were considered as non-responders.
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From the randomization date up to 60 months post the randomization date.
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Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
Временное ограничение: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
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An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.
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From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
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Number of Participants With Any Adverse Event (AE) of Special Interest
Временное ограничение: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
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AEs of special interest included cytopenias (neutropenia [decreased neutrophil count], anaemia [decreased hemoglobin], and thrombocytopenia [decreased platelet count]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.
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From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy
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Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
Временное ограничение: Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
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Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses.
Their normal blood levels indicate proper immune status.
Low levels indicate immuno-suppression.
IgA, IgG, and IgM were measured in the blood samples of the participants.
Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU).
A cycle is defined as the time between one round of treatment until the start of the next round.
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Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
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Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format.
All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays.
Confirmed positives were reported as HAHA positive and titer was determined for each positive sample.
The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.
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From the randomization date up to 60 months post the randomization date.
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Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL.
There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single item scales (social activities [Social Problems (SP) Scale] and future health worries[Future Health (FH) Scale].).
These are measured on a four point scale where 1 = not at all and 4 = very much.
These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems.
EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.
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From the randomization date up to 60 months post the randomization date.
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Mean Health Change Questionnaire (HCQ) Score
Временное ограничение: From the randomization date up to 60 months post the randomization date.
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The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study.
For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study.
A score of 3 or less indicates improvement from Baseline.
HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle[C] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..
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From the randomization date up to 60 months post the randomization date.
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Новообразования
- Лимфопролиферативные заболевания
- Лимфатические заболевания
- Иммунопролиферативные заболевания
- Лейкемия, В-клеточная
- Лейкемия
- Лейкемия, лимфоцитарная, хроническая, B-клеточная
- Лейкемия, лимфоидная
- Противоопухолевые агенты
- Офатумумаб
Другие идентификационные номера исследования
- 114242
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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. .