Исследование аналога JNJ-73763989 + Nucleos(t)Ide у участников, коинфицированных вирусами гепатита B и D (REEF-D)
24 июня 2026 г. обновлено: Janssen Research & Development, LLC
Фаза 2, многоцентровое, рандомизированное, двойное слепое, плацебо-контролируемое исследование с отложенным активным лечением для изучения эффективности, безопасности и фармакокинетики JNJ-73763989 + аналога Nucleos(t)Ide у участников, коинфицированных гепатитом B и гепатитом D Вирус
Целью исследования является оценка эффективности лечения против вируса гепатита D (HDV) схемы JNJ-73763989 + нуклеоз(т)идный аналог (НА) по сравнению с режимом только NA.
Обзор исследования
Статус
Статус
Завершенный
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
JNJ-73763989 представляет собой противовирусное терапевтическое средство, нацеленное на печень, для подкожных инъекций, предназначенное для лечения хронической инфекции, вызванной вирусом гепатита B (HBV), посредством механизма интерференции рибонуклеиновой кислоты.
Это исследование фазы 2 предназначено для оценки безопасности и эффективности JNJ-73763989 у пациентов, инфицированных HBV, которые одновременно инфицированы HDV.
Исследование состоит из 2 частей: в части 1 оценивается безопасность, переносимость и противовирусная активность JNJ-73763989 + NA, а в части 2 оценивается безопасность и эффективность схемы JNJ-73763989 + NA при лечении коинфекции HBV/HDV. .
Каждая часть включает 3 фазы: фаза скрининга (от 4 недель до максимум 8 недель), фаза вмешательства (144 недели для группы A и 148 недель для группы B) и фаза последующего наблюдения (48 недель).
Продолжительность индивидуального участия в исследовании будет составлять от 196 до 204 недель.
Безопасность и переносимость (включая нежелательные явления [НЯ] и серьезные НЯ, лабораторные оценки, электрокардиограмму [ЭКГ], основные показатели жизнедеятельности, физикальное обследование), эффективность (включая рибонуклеиновую кислоту HDV [РНК], дезоксирибонуклеиновую кислоту HBV [ДНК] и антигены) и Фармакокинетика будет оцениваться на протяжении всего исследования.
Тип исследования
Тип исследования
Интервенционный
Регистрация (Действительный)
Регистрация
52
Фаза
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Camperdown, Австралия, 2050
- Royal Prince Alfred Hospital
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Footscray, Австралия, 3011
- Western Health
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Westmead, Австралия, 2145
- Westmead Hospital
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Boa Vista, Бразилия, 69304015
- Centro Oncológico De Roraima
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Manaus, Бразилия, 69040-000
- Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
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Porto Velho, Бразилия, 76812-329
- Cepem - Centro de Pesquisa Em Medicina Tropical
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Essen, Германия, 45147
- Universitätsklinikum Essen
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Frankfurt, Германия, 60590
- Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
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Hanover, Германия, 30625
- Medizinische Hochschule Hannover
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Barcelona, Испания, 8028
- Hosp Clinic de Barcelona
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Barcelona, Испания, 8035
- Hosp Univ Vall D Hebron
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Madrid, Испания, 28041
- Hosp. Univ. 12 de Octubre
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Santander, Испания, 39008
- Hosp. Univ. Marques de Valdecilla
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Milan, Италия, 20122
- Irccs Ospedale Maggiore Di Milano
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Pisa, Италия, 56124
- Azienda Ospedaliero Universitaria Pisana
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Rome, Италия, 00161
- Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
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Torino, Италия, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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Beijing, Китай, 100015
- Beijing Ditan Hospital Capical Medical University
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Beijing, Китай, 100044
- Peking University People s Hospital
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Changchun, Китай, 130021
- The First Bethune Hospital of Jilin University
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Chengdu, Китай, 610041
- West China Hospital Sichuan University
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Chongqing, Китай, 400010
- The Second Affiliated Hospital of Chongqing Medical University
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Guangzhou, Китай, 510515
- Nanfang Hospital
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Guangzhou, Китай, 510000
- Guangzhou Eighth People's Hospital, Guangzhou Medical University
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Hangzhou, Китай, 310003
- The First Affiliated Hospital Zhejiang University College of Medicine
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Shanghai, Китай, 200040
- Huashan Hospital Fudan University
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Auckland, Новая Зеландия, 1010
- New Zealand Clinical Research
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Krasnoyarsk, Россия, 660049
- Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
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Saint Petersburg, Россия, 190103
- St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
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Samara, Россия, 443045
- Medical Company Hepatolog Ltd
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London, Соединенное Королевство, SE5 9RF
- Kings College Hospital
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California
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Redwood City, California, Соединенные Штаты, 94063
- Stanford University School of Medicine
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02114
- Harvard Medical School Massachusetts General Hospital
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Kaohsiung City, Тайвань, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taipei, Тайвань, 10002
- National Taiwan University Hospital
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Tiachung, Тайвань
- China Medical University Hospital
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Istanbul, Турция (Туркие), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Izmir, Турция (Туркие), 35100
- Ege University Medical of Faculty, Department of Gastroenterology
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Kocaeli, Турция (Туркие), 41001
- Kocaeli University Medical Faculty
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Trabzon, Турция (Туркие), 61080
- Karadeniz Teknik University Medical Faculty
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Clichy, Франция, 92110
- Hopital Beaujon
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Lyon, Франция, 69004
- Hôpital de La Croix Rousse
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Nantes, Франция, 44093
- CHU de Nantes hotel Dieu
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Paris, Франция, 75012
- CHU Hopital Saint Antoine
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Rennes, Франция, 35033
- Chu Rennes Hopital Pontchaillou
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Danderyd, Швеция, 18288
- Danderyds Sjukhus
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Malmö, Швеция, 20502
- Skånes universitetssjukhus
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Stockholm, Швеция, 14186
- Karolinska Universitetssjukhuset Huddinge
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Bunkyō City, Япония, 113 8519
- Tokyo Medical and Dental University Hospital
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Hiroshima, Япония, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Iizuka-shi, Япония, 820-8505
- National Hospital Organization Shikoku Cancer Center
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Ikeda, Япония, 563-8510
- Ikeda City Hospital
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Kumamoto, Япония, 860-8556
- Kumamoto University Hospital
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Kumamoto, Япония, 862 8655
- Kumamoto Shinto General Hospital
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Nagasaki, Япония, 852-8501
- Nagasaki University Hospital
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Nagasaki, Япония, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Nakagami Gun, Япония, 903-0215
- University of the Ryukyus hospital
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Okinawa, Япония, 904-2195
- Nakagami Hospital
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Suita, Япония, 564-8567
- Suita Municipal Hospital
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Suita-shi, Япония, 565-0871
- Osaka University Hospital
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Sumida Ku, Япония, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
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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
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 65 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Описание
Критерии включения:
- Состояние стабильное с медицинской точки зрения на основании физического осмотра, истории болезни, основных показателей жизнедеятельности, электрокардиограммы (ЭКГ) при скрининге
- Коинфекция вирусом хронического гепатита B (HBV) и вирусом гепатита D (HDV) с документацией не менее чем за 6 месяцев до скрининга
- Для Части 1: РНК гепатита D (РНК HDV) больше или равно (>=) 1000 международных единиц на миллилитр (МЕ/мл) при скрининге. Для Части 2: значения РНК HDV должны быть >= 500 МЕ/мл, а значения поверхностного антигена гепатита В (HBsAg) должны быть меньше или равны (
- Аланинаминотрансфераза (АЛТ) выше верхней границы нормы (ВГН), но менее чем в 10 раз (ВГН)
- Индекс массы тела (ИМТ) от 18,0 до 35,0 кг на квадратный метр (кг/м^2), включая крайние значения.
- Внедрены высокоэффективные меры контрацепции для участников-женщин детородного возраста или участников-мужчин с партнершами-женщинами детородного возраста
- Участники без цирроза печени и участники с компенсированным циррозом печени (класс А по Чайлд-Пью) при скрининге (Часть 1), а также участники должны иметь отсутствие цирроза печени и количество тромбоцитов >= 140 000 на децилитр (дл) для включения в Часть 2.
Критерий исключения:
- Доказательства инфицирования вирусом гепатита А, С или Е или признаки иммунодефицита человека, заражения вирусом типа 1 (ВИЧ-1) или ВИЧ-2 при скрининге
- История или доказательства клинических признаков/симптомов декомпенсации печени, включая, помимо прочего: портальную гипертензию, асцит, печеночную энцефалопатию, варикозное расширение вен пищевода или любые лабораторные отклонения, указывающие на снижение функции печени, как определено в протоколе.
- Признаки заболевания печени не-HBV/HDV-этиологии
- Признаки гепатоцеллюлярной карциномы (ГЦК)
- Значительные лабораторные отклонения, как определено в протоколе при скрининге
- Участники со злокачественными новообразованиями в анамнезе в течение 5 лет до скрининга
- Аномальный синусовый ритм или параметры ЭКГ при скрининге, как указано в протоколе
- История или текущая сердечная аритмия или история или клинические признаки значительного или нестабильного сердечного заболевания
- Участники с любым текущим или предыдущим заболеванием, участие в котором, по мнению исследователя и/или спонсора, не отвечает интересам участника.
- История или текущее клинически значимое кожное заболевание или лекарственная сыпь
- Участники с известной аллергией, гиперчувствительностью или непереносимостью JNJ-3989 или его наполнителей или наполнителей плацебо
- Противопоказания к применению энтекавира (ETV), тенофовира дизопроксила или тенофовира алафенамида (TAF) в соответствии с местными инструкциями по применению
- Участники, принимавшие какие-либо методы лечения, запрещенные протоколом
- Участники женского пола, которые беременны, кормят грудью или планируют забеременеть, пока они включены в это исследование или в течение 90 дней после последней дозы исследуемого вмешательства.
- Участники мужского пола, которые планируют стать отцом ребенка во время зачисления
- Участники, перенесшие или запланировавшие серьезную операцию (например, требующую общей анестезии) или получившие трансплантацию органов
- Уязвимые участники (например, лица, находящиеся в заключении, лица, которым назначена мера правовой защиты)
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: Параллельное назначение
- Маскировка: Двойной
Количество рук
2
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
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Экспериментальный: Группа немедленного активного лечения: JNJ-73763989 + NA
Участники будут получать подкожную (п/к) инъекцию JNJ-73763989 каждые 4 недели (Q4W) вместе с NA (энтекавир [ETV], тенофовир дизопроксил или тенофовир алафенамид [TAF]) один раз в день в течение 144 недель в части 1 и в течение как минимум 96 недель. в Части 2.
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Таблетки тенофовира дизопроксила, покрытые пленочной оболочкой, будут вводиться перорально.
JNJ-73763989 будет вводиться в виде подкожной инъекции.
Другие имена:
Таблетки, покрытые пленочной оболочкой моногидрата ETV, будут вводиться перорально.
Таблетки ТАФ, покрытые пленочной оболочкой, следует принимать перорально.
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Плацебо Компаратор: Группа отсроченного активного лечения: плацебо+NA+JNJ-73763989+NA
Участники будут получать плацебо, соответствующее JNJ-73763989, подкожную инъекцию каждые 4 недели вместе с NA (ETV, тенофовир дизопроксилом или TAF) один раз в день в течение 52 недель, а затем подкожную инъекцию JNJ-73763989 Q4W вместе с NA один раз в день в течение 96 недель в Части 1 и для не менее 48 недель в Части 2.
|
Таблетки тенофовира дизопроксила, покрытые пленочной оболочкой, будут вводиться перорально.
JNJ-73763989 будет вводиться в виде подкожной инъекции.
Другие имена:
Таблетки, покрытые пленочной оболочкой моногидрата ETV, будут вводиться перорально.
Таблетки ТАФ, покрытые пленочной оболочкой, следует принимать перорально.
Плацебо, соответствующее JNJ-73763989, будет вводиться в виде подкожной инъекции.
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Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Временное ограничение: Week 48
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Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT less than (<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach)
Временное ограничение: Week 48
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Parts 1 and 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA < Lower Limits of Quantification (LLOQ) at Week 48
Временное ограничение: Week 48
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA < LLOQ at Week 48 was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48
Временное ограничение: Week 48
|
Percentage of participants with normal ALT at Week 48 was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48
Временное ограничение: Week 48
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Percentage of participants with HBsAg seroclearance at Week 48 was reported.
HBsAg seroclearance was defined as HBsAg negativity (quantitative HBsAg level <LLOQ) based on the assay used.
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Week 48
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Parts 1 and 2: Percentage of Participants With >=2 Kilopascal (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) (FibroScan) at Week 48
Временное ограничение: Week 48
|
Percentage of participants with >=2 kPa reduction from baseline in LSM assessed by VCTE (fibroscan) at Week 48 was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Week 48
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Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48, FU Week 24
|
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Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48, FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
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Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA TND in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
TND was defined as no traces of HBV RNA were detected/found.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Временное ограничение: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA TND
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
|
Week 48, FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA TND
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
|
Week 48, FU Week 24
|
|
Part 1: Percentage of Participants With Normal ALT
Временное ограничение: FU Week 24
|
Percentage of participants with Normal ALT was reported.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
|
FU Week 24
|
|
Part 2: Percentage of Participants With Normal ALT
Временное ограничение: FU Week 24
|
Percentage of participants with Normal ALT was reported.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
|
FU Week 24
|
|
Parts 1 and 2: Time to Reach HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Временное ограничение: Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
|
Time to reach HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was planned to be reported.
It is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HDV RNA >= 2 log10 IU/mL decline or HDV RNA TND, whichever event is first (that is, minute [the date of the first HDV RNA >= 2 log10 IU/mL decline, date of the first time HDV RNA is TND] - the date of first study intervention intake + 1).
TND was defined as no traces of HBV RNA were detected/found.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
|
|
Part 1: Change From Baseline in HDV RNA
Временное ограничение: Baseline (Day 1), Week 48
|
Change from baseline in HDV RNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48
|
|
Part 2: Change From Baseline in HDV RNA
Временное ограничение: Baseline (Day 1), Week 48
|
Change from baseline in HDV RNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48
|
|
Part 1: Change From Baseline in ALT
Временное ограничение: Baseline (Day 1), Week 48, FU Week 24
|
Change from baseline in ALT was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 24
|
|
Part 2: Change From Baseline in ALT
Временное ограничение: Baseline (Day 1), Week 48, FU Week 44
|
Change from baseline in ALT was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 44
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with TEAEs was reported.
An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention.
TEAE were all AEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with TESAEs was reported.
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
TESAE were all SAEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: chemistry was reported.
Laboratory abnormalities were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
ALT: Alanine Aminotransferase; AST: Aspartate Aminotransferase; SGPT: serum glutamic pyruvic transaminase; SGOT: serum glutamic-oxaloacetic transaminase.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Hematology
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
|
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: hematology was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
|
Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urinalysis was reported.
Urinalysis included parameters: Glycosuria, Hematuria, and Proteinuria.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urine chemistry was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: renal biomarkers was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
Percentage of participants with worst treatment-emergent abnormalities in 12-Lead Electrocardiogram was reported.
Only those parameters were reported where at least one participant had abnormality.
Worst ECG abnormalities were determined based on investigator's discretion.
bpm: beats per minute; ms: milliseconds; QTcF: QT interval corrected for heart rate according to Fridericia; QTc: Corrected QT Interval.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144
|
Percentage of participants with worst treatment-emergent abnormalities in vital signs (pulse rate, supine systolic blood pressure).
Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
Only those parameters were reported where at least one participant had abnormality.
Abn: abnormal
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144
|
|
Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
Временное ограничение: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with clinically significant abnormalities in physical examination was reported.
Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
|
Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
|
|
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBsAg seroclearance was reported.
HBsAg seroclearance is defined as the quantitative HBsAg < LLOQ.
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Week 48, FU Week 24
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Part 1: Change From Baseline Over Time in HBsAg
Временное ограничение: Baseline (Day 1), Week 48, FU Week 24
|
Change from baseline over time in HBsAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 24
|
|
Part 2: Change From Baseline Over Time in HBsAg
Временное ограничение: Baseline (Day 1), Week 48, FU Week 24
|
Change from baseline over time in HBsAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 24
|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus e Antigen (HBeAg)
Временное ограничение: Baseline (Day 1), Week 48, FU Week 24
|
Change from baseline over time in HBeAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 24
|
|
Part 2: Change From Baseline Over Time in HBeAg
Временное ограничение: Baseline (Day 1), Week 48, FU Week 24
|
Change from baseline over time in HBeAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 24
|
|
Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Временное ограничение: Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
|
Change from baseline over time in HBV DNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
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|
Part 2: Change From Baseline Over Time in HBV DNA
Временное ограничение: Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
|
Change from baseline over time in HBV DNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
|
|
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBsAg levels below/above different cut-offs was reported.
HBsAg values (IU/mL) were <1,000, <100, <10, <1, and <0.05 IU/mL (i.e, <LLOQ).
LLOQ value is 0.05 IU/mL.
|
Week 48, FU Week 24
|
|
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBsAg levels below/above different cut-offs was reported.
HBsAg values (IU/mL) were <1,000, <100, <10, <1, and <0.05 IU/mL (i.e, <LLOQ).
LLOQ value is 0.05 IU/mL.
|
Week 48, FU Week 24
|
|
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBeAg levels below/above different cut-offs was reported.
Cut-offs were >= 0.5 log10 IU/mL, >= 1.0 log10 IU/mL, >= 2.0 log10 IU/mL, and >= 3.0 log10 IU/mL.
|
Week 48, FU Week 24
|
|
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBeAg levels below/above different cut-offs was reported.
Cut-offs were >= 0.5 log10 IU/mL, >= 1.0 log10 IU/mL, >= 2.0 log10 IU/mL, and >= 3.0 log10 IU/mL.
|
Week 48, FU Week 24
|
|
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBV DNA levels below/above different cut-offs (<LLOQ and <2000 IU/mL) was reported.
For HBV DNA, LLOQ is 20 IU/mL.
|
Week 48, FU Week 24
|
|
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBV DNA levels below/above different cut-offs (<LLOQ and <2000 IU/mL).
For HBV DNA, LLOQ is 20 IU/mL
|
Week 48, FU Week 24
|
|
Part 1: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Временное ограничение: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
|
Time to reach HBsAg <1 IU/mL based on Kaplan-Meier estimate was reported.
Time to first occurrence of the HBsAg <1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg <1 IU/mL.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
|
|
Part 2: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Временное ограничение: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
|
Time to reach HBsAg <1 IU/mL based on Kaplan-Meier estimate was reported.
Time to first occurrence of the HBsAg <1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg <1 IU/mL.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
|
|
Part 1: Percentage of Participants With HBV DNA Virologic Breakthrough
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBV DNA virologic breakthrough was reported.
Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level <LLOQ of the HBV DNA assay.
|
Week 48, FU Week 24
|
|
Part 2: Percentage of Participants With HBV DNA Virologic Breakthrough
Временное ограничение: Week 48, FU Week 24
|
Percentage of participants with HBV DNA virologic breakthrough was reported.
Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level <LLOQ of the HBV DNA assay.
|
Week 48, FU Week 24
|
|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Временное ограничение: Weeks 4, 8, and 16
|
Maximum plasma concentration (Cmax) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
|
Weeks 4, 8, and 16
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|
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Временное ограничение: Weeks 4, 8, and 16
|
Maximum plasma concentration (Cmax) of JNJ-3924 was reported.
Participant wise data is reported as n<3.
|
Weeks 4, 8, and 16
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Временное ограничение: Predose up to 24 hours post dose on Weeks 4, 8, and 16
|
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[0-24h]) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
|
Predose up to 24 hours post dose on Weeks 4, 8, and 16
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Временное ограничение: Predose up to 24 hours post dose on Weeks 4, 8, and 16
|
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[0-24h]) of JNJ-3924 were reported.
Participant wise data is reported as n<3.
|
Predose up to 24 hours post dose on Weeks 4, 8, and 16
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Временное ограничение: Weeks 4, 8, and 16
|
Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
|
Weeks 4, 8, and 16
|
|
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Временное ограничение: Weeks 4, 8, and 16
|
Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924 were reported.
Participant wise data is reported as n<3.
|
Weeks 4, 8, and 16
|
|
Part 1: Percentage of Participants With >=2 Kilopascals (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE; FibroScan)
Временное ограничение: Baseline, EOS (FU Week 48)
|
Percentage of participants with >=2 kPa reduction from baseline >=2 kPa in liver stiffness measurement (LSM) assessed by VCTE (fibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline, EOS (FU Week 48)
|
|
Part 2: Percentage of Participants With >=2 kPa Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by VCTE (FibroScan)
Временное ограничение: Baseline, EOS (FU Week 48)
|
Percentage of participants with >=2 kPa reduction from baseline in liver stiffness measurement (LSM) assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline, EOS (FU Week 48)
|
|
Part 1: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Временное ограничение: Baseline, Week 48, FU Week 24
|
Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline, Week 48, FU Week 24
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Part 2: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Временное ограничение: Baseline, Week 48, FU Week 24
|
Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline, Week 48, FU Week 24
|
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Part 1: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported.
A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
|
Part 2: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported.
A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
|
JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
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Part 1: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported.
Off-treatment HDV relapse is defined as: 1.
In participants with HDV RNA <LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment.
2. In participants with HDV RNA >LLOQ at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
|
Part 2: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported.
Off-treatment HDV relapse is defined as: 1.
In participants with HDV RNA <LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment.
2. In participants with HDV RNA >LLOQ at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
|
JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
|
Parts 1 and 2: Percentage of Participants With Sustained HBV Response Off-treatment Post End of JNJ-3989 Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with sustained HBV response off-treatment post end of JNJ-3989 treatment was reported.
|
JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
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Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported.
Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA).
Virologic flare is for participants who are off-treatment and had HBV DNA < LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL.
Biochemical HBV flare is defined as a confirmed ALT and/or AST>=3*ULN and >=3* nadir (i.e.
lowest value observed up to the time point of meeting the biochemical flare criteria).
An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
|
Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Временное ограничение: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported was reported.
Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA).
Virologic flare (Derivation 1) is for participants who are off-treatment and had HBV DNA < LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL.
Biochemical HBV flare is defined as a confirmed ALT and/or AST>=3*ULN and >=3* nadir (i.e.
lowest value observed up to the time point of meeting the biochemical flare criteria).
An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
|
JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Спонсор
Следователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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)
Начало исследования
17 сентября 2020 г.
Первичное завершение (Действительный)
Первичное завершение
19 октября 2023 г.
Завершение исследования (Действительный)
Завершение исследования
5 марта 2025 г.
Даты регистрации исследования
Первый отправленный
Первый отправленный
28 августа 2020 г.
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
1 сентября 2020 г.
Первый опубликованный (Действительный)
Первый опубликованный
2 сентября 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
22 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
24 июня 2026 г.
Последняя проверка
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Хроническое заболевание
- Атрибуты болезни
- Инфекции
- РНК-вирусные инфекции
- Вирусные заболевания
- Заболевания пищеварительной системы
- Заболевания печени
- Гепатит, Вирусный, Человеческий
- Гепатит, хронический
- Гепатит
- Патологические состояния, признаки и симптомы
- Гепатит Д
- Гепатит D, хронический
- Органические химические вещества
- Гетероциклические соединения
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Пурины
- Соединения органофосфора
- Органофосфонаты
- Аденин
- Тенофовир
- Тенофовир Алафенамид
- Энтекавир
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- CR108868
- 2020-001249-37 (Номер EudraCT)
- 73763989HPB2004 (Другой идентификатор: Janssen Research & Development, LLC)
- 2023-506763-33-00 (Идентификатор реестра: EUCT number)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Политика обмена данными фармацевтических компаний Janssen компании Johnson & Johnson доступна на сайте www.janssen.com/clinical-trials/transparency.
Как указано на этом сайте, запросы на доступ к данным исследования можно отправить через сайт проекта Yale Open Data Access (YODA) по адресу yoda.yale.edu.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов 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. .