Исследование GSK3965193 у здоровых участников, а также отдельно и в комбинации с бепировирсеном у участников, живущих с хроническим гепатитом В.
19 мая 2026 г. обновлено: GlaxoSmithKline
Четырехчастное рандомизированное двойное слепое (части 1, 2A, 3 и 4) многоцентровое плацебо-контролируемое исследование для оценки безопасности, переносимости, фармакокинетики и фармакодинамики монотерапии GSK3965193 у здоровых участников и у участников, живущих с Хроническая инфекция гепатита В; и GSK3965193 в комбинации с бепировирсеном у участников, живущих с хроническим гепатитом В.
Это многоэтапное исследование фазы 1/2a представляет собой первое исследование на людях (FTIH), предназначенное для оценки безопасности, переносимости и фармакокинетики (ФК) однократных (часть 1) и повторных доз (часть 2) GSK3965193 в здоровые участники.
В части 3 будет оцениваться способность GSK3965193 снижать поверхностный антиген вируса гепатита В (HBsAg) у участников, живущих с хронической инфекцией гепатита В (PLWCHB).
В части 4 будут оцениваться безопасность и переносимость комбинированной терапии с GSK3965193 и бепировирсеном, а также возможность воздействия на устойчивый вирусологический ответ у PLWCHB.
Обзор исследования
Статус
Прекращено
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
74
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Milan, Италия, 20122
- GSK Investigational Site
-
Monza MB, Италия, 20900
- GSK Investigational Site
-
-
-
-
Alberta
-
Calgary, Alberta, Канада, T2N 4Z6
- GSK Investigational Site
-
-
Ontario
-
Ottawa, Ontario, Канада, K1H 8L6
- GSK Investigational Site
-
-
-
-
-
Cambridge, Соединенное Королевство, CB2 2GG
- GSK Investigational Site
-
London, Соединенное Королевство, SW17 0QT
- GSK Investigational Site
-
London, Соединенное Королевство, W2 1NY
- GSK Investigational Site
-
-
-
-
-
Bangkok, Таиланд, 10330
- GSK Investigational Site
-
-
-
-
-
Grenoble, Франция, 38043
- GSK Investigational Site
-
Nantes, Франция, 44000
- GSK Investigational Site
-
Rennes, Франция, 35033
- GSK Investigational Site
-
-
-
-
-
Daegu, Южная Корея, 41944
- GSK Investigational Site
-
Pusan, Южная Корея, 49241
- GSK Investigational Site
-
Seoul, Южная Корея, 05505
- GSK Investigational Site
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 65 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Описание
Критерии включения:
- Части 1 и 2: Участники в возрасте от 18 до 55 лет включительно на момент подписания информированного согласия.
- Части 3 и 4: Участники в возрасте от 18 до 65 лет включительно на момент подписания информированного согласия.
- Масса тела >=50 кг (кг) и индекс массы тела в пределах 18-32 кг на квадратный метр (кг/м^2) (включительно).
- Участник мужского или женского пола: a. Части 1 и 2: только женщины недетородного возраста. б. Части 3 и 4: женщина недетородного возраста или женщина детородного возраста, которая не беременна или не кормит грудью и использует высокоэффективный метод контрацепции.
- Способен дать подписанное информированное согласие.
- Дополнительные критерии включения ЛЖКН (части 3 и 4).
- Участники, у которых задокументирована хроническая инфекция вируса гепатита В (ВГВ) >= 6 месяцев до скрининга.
- Участники, в настоящее время получающие стабильную терапию NA (например, тенофовир дизопроксил, тенофовир алафенамид, энтекавир).
- Концентрация HBsAg в плазме или сыворотке >100 МЕ/мл.
- Концентрация дезоксирибонуклеиновой кислоты (ДНК) HBV в плазме или сыворотке
- Е-антиген вируса гепатита В (HBeAg) положительный или отрицательный.
- Аланинаминотрансфераза (АЛТ)
Критерий исключения:
- Критерии исключения для здоровых участников:
- Положительный результат на антитела к вирусу гепатита А (HAV Ab иммуноглобулин M [IgM]) или положительный результат на HBV, вирус гепатита C (HCV) или вирус иммунодефицита человека (ВИЧ) при скрининге.
- АЛТ >1 раза ВГН.
- Билирубин >1,5 раза выше ВГН (выделенный билирубин >1,5 раза выше ВГН допустим, если билирубин фракционирован, а прямой билирубин
- Скорректированный интервал QT (QTc) > 450 миллисекунд (мс).
- Признаки и симптомы, указывающие на коронавирусную болезнь 2019 (COVID-19).
- Участники с известными положительными контактами с COVID-19 за последние 14 дней.
- Для участников Части 2A: i. Личная или семейная история периферической невропатии. II. Оценка >=4 по клинической системе оценки Торонто для полинейропатии.
- Текущее или предыдущее употребление табака или никотинсодержащих продуктов (например, (например) сигарет, никотиновых пластырей или электронных устройств) в течение 6 месяцев до скрининга и / или наличие пачки курения > 5 лет пачки.
- Критерии исключения для PLWCHB:
- Клинически значимые отклонения в анамнезе, кроме хронической инфекции ВГВ.
- Коинфекция или наличие в анамнезе ВГС, ВИЧ или вируса гепатита D (HDV).
- История или подозрение на цирроз печени и / или признаки цирроза.
- Диагностированная или предполагаемая гепатоцеллюлярная карцинома.
- История злокачественных новообразований в течение последних 5 лет, за исключением конкретных видов рака, которые излечиваются хирургической резекцией (например, рак кожи).
- Васкулит в анамнезе или наличие симптомов и признаков потенциального васкулита [например, васкулитная сыпь, изъязвление кожи, повторное обнаружение крови в моче без установленной причины] или наличие в анамнезе других заболеваний, которые могут быть связаны с состоянием васкулита (например, системная красная волчанка). ревматоидный артрит, рецидивирующий полихондрит, множественный мононеврит).
- Внепеченочные расстройства в анамнезе, возможно, связанные с иммунными состояниями ВГВ (например, нефротический синдром, любой тип гломерулонефрита, узелковый полиартериит, криоглобулинемия, неконтролируемая артериальная гипертензия).
- Злоупотребление алкоголем или наркотиками/зависимость в анамнезе: a. Текущее употребление алкоголя, по мнению исследователя, может помешать соблюдению требований участниками. б. История или текущая зависимость/злоупотребление наркотиками, по мнению исследователя, потенциально может помешать соблюдению требований участниками.
- История или другие доказательства кровотечения из варикозно расширенных вен пищевода.
- Документально подтвержденный анамнез или другие признаки метаболического заболевания печени в течение 1 года после рандомизации.
- Личная или семейная история периферической невропатии.
- Оценка > 4 по клинической системе оценки Торонто для полинейропатии.
- История получения или получения в настоящее время любого системного противоопухолевого (включая облучение) или иммуномодулирующего лечения (включая системные пероральные кортикостероиды, интерферон или пегилированный интерферон) в течение 8 недель до первой дозы исследуемого препарата или ожидание того, что такое лечение понадобится в любой момент обучения.
- Аномальные и клинически значимые изменения ЭКГ в 12 отведениях.
- Принимаете в настоящее время или принимали в течение 3 месяцев после скрининга какие-либо иммунодепрессанты (например, преднизолон), кроме короткого курса терапии (
- Участники, нуждающиеся в антикоагулянтной терапии.
- Предшествующее лечение любым олигонуклеотидом или малой интерферирующей РНК (миРНК) в течение 12 месяцев до первого дня дозирования.
- Положительный тест на инфекцию COVID-19.
- Участники с известными положительными контактами с COVID-19 за последние 14 дней.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Part 1: Cohort 1 - Placebo/GSK3965193 Dose 2/Dose 3/Dose 4
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 2.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 1 - GSK3965193 Dose 1/Placebo/Dose 3/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 1.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Placebo/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Dose 3/Placebo
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 3 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 2 - Placebo/GSK3965193 Dose 6/Dose 7/Dose 8
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 6.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 2 - GSK3965193 Dose 5/Placebo/Dose 7/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 5.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Placebo/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Dose 7/Placebo
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 7 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Плацебо Компаратор: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
|
Placebo to match GSK3965193 was administered
|
|
Экспериментальный: Part 2A: Cohort 5 - GSK3965193 Dose 9 BID
Healthy participants received repeat doses of GSK3965193 Dose 9 oral solution BID for 14 days.
Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
|
GSK3965193 was administered
|
|
Экспериментальный: Part 2A: Cohort 3 - GSK3965193 Dose 5 BID
Healthy participants received repeat doses of GSK3965193 Dose 5 oral solution BID for 14 days.
Dose 5 of GSK3965193 was higher than Dose 9 but lower than Dose 10.
|
GSK3965193 was administered
|
|
Экспериментальный: Part 2A: Cohort 4 - GSK3965193 Dose 6 BID
Healthy participants received repeat doses of GSK3965193 Dose 6 oral solution BID for 14 days.
Dose 6 of GSK3965193 was higher than Dose 10 but lower than Dose 7.
|
GSK3965193 was administered
|
|
Экспериментальный: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fasted/Fed
Healthy participants received GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
|
GSK3965193 was administered
|
|
Экспериментальный: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fed/Fasted
Healthy participants received GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
|
GSK3965193 was administered
|
|
Плацебо Компаратор: Part 3: Cohort 7 - Placebo
Participants living with chronic hepatitis B infection (PLWCHB) on stable nucleos(t)ide analog (NA) therapy received repeat doses of placebo oral tablets for 28 days.
Participants who completed placebo monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen subcutaneous (SC) injection from Day 43.
|
Placebo to match GSK3965193 was administered
Bepirovirsen was administered
|
|
Экспериментальный: Part 3: Cohort 7 - GSK3965193 Dose 9
PLWCHB on stable NA therapy received repeat doses of GSK3965193 Dose 9 oral tablets for 28 days.
Participants who completed GSK3965193 monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen SC injection from Day 43.
Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
|
GSK3965193 was administered
Bepirovirsen was administered
|
|
Экспериментальный: Part 4: Cohort 8 - Placebo + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive placebo oral tablets plus bepirovirsen SC injection for 28 days.
All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
|
Placebo to match GSK3965193 was administered
Bepirovirsen was administered
|
|
Экспериментальный: Part 4: Cohort 8 - GSK3965193 + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive GSK3965193 oral tablets plus bepirovirsen SC injection for 28 days.
All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
|
GSK3965193 was administered
Bepirovirsen was administered
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Временное ограничение: From the start of study intervention (Day 1) up to 12 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration.
Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
|
From the start of study intervention (Day 1) up to 12 weeks
|
|
Part 2A: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Временное ограничение: From the start of study intervention (Day 1) up to 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date.
|
From the start of study intervention (Day 1) up to 6 weeks
|
|
Part 2B: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Временное ограничение: From the start of study intervention (Day 1) up to 9 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration.
Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
|
From the start of study intervention (Day 1) up to 9 weeks
|
|
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Временное ограничение: From the start of study intervention (Day 1) up to 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE was considered treatment emergent if the AE onset or worsen date was on or after study intervention start date.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
From the start of study intervention (Day 1) up to 6 weeks
|
|
Part 4: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Временное ограничение: From the start of study intervention (Day 1) up to 48 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
An AE would be considered treatment emergent if the AE onset or worsen date was on or after study intervention start date.
|
From the start of study intervention (Day 1) up to 48 weeks
|
|
Part 1: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Временное ограничение: At Day 2
|
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, RBC indices (mean corpuscular volume [MCV] and mean corpuscular hemoglobin [MCH]), white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Clinical significance of laboratory parameters was determined by the investigator.
|
At Day 2
|
|
Part 2A: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Временное ограничение: Up to 21 days
|
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
|
Up to 21 days
|
|
Part 2B: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Временное ограничение: Up to 9 weeks
|
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
|
Up to 9 weeks
|
|
Part 3: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Временное ограничение: Up to 35 days
|
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Clinical significance of laboratory parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
Up to 35 days
|
|
Part 3: Number of Participants With Clinically Significant Urinalysis Parameters
Временное ограничение: Up to 28 days
|
Urine samples were analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
Up to 28 days
|
|
Part 4: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Временное ограничение: Up to 48 weeks
|
Blood samples were planned to be collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin.
Urine samples were planned to be analyzed using automated urinalysis or urine dipstick.
Microscopic examination was planned to be performed if abnormal blood or protein was present in the urine sample.
Clinical significance of laboratory parameters would be determined by the investigator.
|
Up to 48 weeks
|
|
Part 1: Number of Participants With Clinically Significant Vital Sign Findings
Временное ограничение: Up to 12 weeks
|
Vital signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
|
Up to 12 weeks
|
|
Part 2A: Number of Participants With Clinically Significant Vital Sign Findings
Временное ограничение: Up to 21 days
|
Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
|
Up to 21 days
|
|
Part 2B: Number of Participants With Clinically Significant Vital Sign Findings
Временное ограничение: Up to 9 weeks
|
Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
|
Up to 9 weeks
|
|
Part 3: Number of Participants With Clinically Significant Vital Sign Findings
Временное ограничение: Up to 35 days
|
Vital signs included temperature, SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
Up to 35 days
|
|
Part 4: Number of Participants With Clinically Significant Vital Signs Findings
Временное ограничение: Up to 48 weeks
|
Vital signs were planned to include temperature, SBP and DBP, pulse and respiratory rate and were planned to be measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of the vital sign findings would be determined by the investigator.
|
Up to 48 weeks
|
|
Part 1: Number of Participants With Clinically Significant Electrocardiogram [ECG] Findings
Временное ограничение: Up to 12 weeks
|
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and corrected QT (QTc) intervals.
Clinical significance of ECG parameters was determined by the investigator.
|
Up to 12 weeks
|
|
Part 2A: Number of Participants With Clinically Significant ECG Findings
Временное ограничение: Up to 21 days
|
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG parameters was determined by the investigator.
|
Up to 21 days
|
|
Part 3: Number of Participants With Clinically Significant ECG Findings
Временное ограничение: Up to 35 days
|
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG parameters was determined by the investigator.
Data for the placebo or GSK3965193 monotherapy phase were presented.
|
Up to 35 days
|
|
Part 4: Number of Participants With Clinically Significant ECG Findings
Временное ограничение: Up to 25 weeks
|
A 12-lead ECG was planned to be recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine.
The parameters planned to be collected were PR, QRS, QT, and QTc intervals.
Clinical significance of ECG findings would be determined by the investigator.
|
Up to 25 weeks
|
|
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 7
Временное ограничение: Baseline and Day 7
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
Nerve conduction velocity (NCV) and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25 percent (%) decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 7 was reported.
|
Baseline and Day 7
|
|
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 14
Временное ограничение: Baseline and Day 14
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 14 was reported.
|
Baseline and Day 14
|
|
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 42
Временное ограничение: Baseline and Day 42
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing.
Mean (arithmetic mean) of two measurements were considered as Baseline.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 42 was reported.
|
Baseline and Day 42
|
|
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 15
Временное ограничение: Baseline and Day 15
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 15 for the placebo or GSK3965193 monotherapy phase was reported.
|
Baseline and Day 15
|
|
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 29
Временное ограничение: Baseline and Day 29
|
Sensory nerve conduction testing was performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were determined.
The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 29 for the placebo or GSK3965193 monotherapy phase was reported.
|
Baseline and Day 29
|
|
Part 4: Number of Participants With Changes in Sensory Nerve Conduction
Временное ограничение: Baseline up to 29 days
|
Sensory nerve conduction testing was planned to be performed to detect neuropathy in participants.
NCV and nerve conduction amplitude were planned to be determined.
Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from baseline was planned to be reported.
|
Baseline up to 29 days
|
|
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
|
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
|
|
Part 2A: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
As the dosing interval Tau was 12 hours, AUC(0-tau) is the same as AUC from time zero to 12 hours after dosing (AUC[0-12]).
|
Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
|
|
Part 1: Maximum Observed Concentration (Cmax) of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: Cmax of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
|
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: Tmax of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
|
Part 1: Apparent Terminal Half-life (T1/2) of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
|
|
Part 2A: T1/2 of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
|
|
Part 3: Maximum Reduction of Serum HBsAg Levels From Baseline
Временное ограничение: From Baseline (Pre-dose on Day 1) up to 6 weeks
|
Blood samples were collected from participants to assess HBsAg levels for the placebo or GSK3965193 monotherapy phase.
Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Posterior mean and associated 95 percent (%) credible interval were derived for maximum reduction of serum HBsAg levels from Baseline using Bayesian mixed model repeated measures.
The data presented are mean referring to posterior mean, with 95% confidence interval referring to 95% credible interval.
|
From Baseline (Pre-dose on Day 1) up to 6 weeks
|
|
Part 4: Number of Participants Achieving Complete Response
Временное ограничение: Up to 48 weeks
|
Blood samples were planned to be collected to assess HBsAg and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels.
Complete response is defined HBsAg and HBV DNA below lower limit of quantification (LLOQ) for 6 consecutive months after the planned end of treatment.
|
Up to 48 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
|
Part 2B: Cmax of GSK3965193 Following Single Dose Administration
Временное ограничение: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
|
|
Part 3: AUC(0-tau) of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Cmax of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Tmax of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: T1/2 of GSK3965193 Following Repeat Dose Administration
Временное ограничение: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
Blood samples were collected at indicated time points for PK analysis of GSK3965193.
PK analysis was conducted using standard non-compartmental methods.
|
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
|
|
Part 3: Number of Participants With Greater Than or Equal to [≥] 0.5 Times Log International Units Per Milliliters [IU/mL] Reduction From Baseline in Serum HBsAg Levels
Временное ограничение: From Baseline (Day 1) up to 42 days
|
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
|
From Baseline (Day 1) up to 42 days
|
|
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs Among Participants Opting for Optional Bepirovirsen Treatment
Временное ограничение: From the start of study intervention up to 54 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
|
From the start of study intervention up to 54 weeks
|
|
Part 3: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters Among Participants Opting for Optional Bepirovirsen Treatment
Временное ограничение: From Week 7 up to 54 weeks
|
Blood samples were planned to be collected to analyze clinical chemistry and hematology parameters: hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium corrected for albumin, creatinine, glucose, potassium, and sodium.
Urine samples were planned to be analyzed using automated urinalysis or urine dipstick.
Microscopic examination was performed if abnormal blood or protein was present in the urine sample.
Number of participants with clinically significant clinical chemistry, hematology, and urinalysis parameters were reported.
Clinical significance was determined by the investigator.
|
From Week 7 up to 54 weeks
|
|
Part 3: Number of Participants With Clinically Significant Vital Signs Among Participants Opting for Optional Bepirovirsen Treatment
Временное ограничение: From Week 7 up to 54 weeks
|
Vital signs were planned to include temperature and were planned to be measured with the participant in semi-supine position after 5 minutes rest.
Clinical significance of vital signs was determined by the investigator.
|
From Week 7 up to 54 weeks
|
|
Part 4: Number of Participants With HBsAg Loss
Временное ограничение: Up to 48 weeks
|
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
HBsAg loss is defined by two consecutive measurements of HBsAg below the LLOQ any time during the study (on-treatment and post-treatment).
|
Up to 48 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: GSK Clinical Trials, GlaxoSmithKline
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
14 апреля 2022 г.
Первичное завершение (Действительный)
19 мая 2025 г.
Завершение исследования (Действительный)
8 апреля 2026 г.
Даты регистрации исследования
Первый отправленный
8 апреля 2022 г.
Впервые представлено, что соответствует критериям контроля качества
8 апреля 2022 г.
Первый опубликованный (Действительный)
15 апреля 2022 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
19 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Инфекции, передающиеся через кровь
- Патологические процессы
- Хроническое заболевание
- Атрибуты болезни
- Инфекции
- Вирусные заболевания
- Заболевания пищеварительной системы
- Заболевания печени
- Гепатит, Вирусный, Человеческий
- Передающиеся заболевания
- ДНК-вирусные инфекции
- Гепаднавирусные инфекции
- Гепатит, хронический
- Гепатит
- Патологические состояния, признаки и симптомы
- Гепатит Б
- Гепатит В, хронический
Другие идентификационные номера исследования
- 214760
- 2021-005117-13 (Номер EudraCT)
- 2023-509684-24 (Другой идентификатор: EU CTR)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
IPD для этого исследования будет доступен через сайт запроса данных клинического исследования.
Сроки обмена IPD
IPD будет доступен в течение 6 месяцев после публикации результатов первичных конечных точек, ключевых вторичных конечных точек и данных по безопасности исследования.
Критерии совместного доступа к IPD
Доступ предоставляется после подачи исследовательского предложения и его одобрения Независимой экспертной группой, а также после заключения Соглашения об обмене данными.
Доступ предоставляется на первоначальный период в 12 месяцев, но при необходимости может быть предоставлено продление еще на 12 месяцев.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
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. .