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Open-Label Study of AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a in Subjects With Chronic Hepatitis B Infection

Название протокола
Клинические исследование Chronic Hepatitis b: AB-729, Peg-IFNα-2a - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Arbutus Biopharma Corporation

Источник Arbutus Biopharma Corporation
Краткое содержание

This is a randomized, open label, multicenter Phase 2 study investigating the safety and antiviral activity of AB-729 in combination with ongoing NA therapy and short courses of Peg-IFNα-2a in subjects with CHB.
Общий статус Recruiting
Дата начала 2021-10-29
Дата завершения 2024-08-01
Дата первичного завершения 2023-03-01
Фаза Phase 2
Тип исследования Interventional
Первичный результат
Мера Временное ограничение
The frequency and severity of treatment emergent adverse events (TEAEs), discontinuations due to adverse events (AEs), and laboratory abnormalities after dosing with AB-729 plus Peg-IFNα-2a Up to 124 weeks
Вторичный результат
Мера Временное ограничение
Change from baseline in HBsAg and other virologic markers at each time point Up to 124 weeks
Proportion of subjects with HBsAb seroconversion at each timepoint Up to 124 weeks
Proportion of subjects who are eligible to stop NA after Week 24 of follow up Up to 76 weeks
Proportion of subjects who discontinue NA and subsequently restart NA therapy after meeting criteria Up to 124 weeks
Proportion of subjects who discontinue NA and subsequently meet protocol defined clinical relapse criteria. Proportion of subjects who discontinue NA and subsequently meet protocol defined viral relapse criteria Up to 124 weeks
Post-dose plasma concentrations of AB-729 anti-sense (AS), AB-729 AS(N-1)3', and AB-729 AS(N-2)3' at selected timepoints Up to 40 weeks
Регистрация 40
Состояние
  • Chronic Hepatitis b
Вмешательство

Тип вмешательства: Drug

Название вмешательства: AB-729

Описание: subcutaneous injection

Тип вмешательства: Drug

Название вмешательства: Peg-IFNα-2a

Описание: subcutaneous injection

Другое имя: pegylated interferon alpha 2a

Приемлемость

Критерии:

Inclusion Criteria: - Chronic hepatitis B virus infection with documentation at least 6 months prior to screening - Subjects must have been receiving either TAF, TDF (or equivalent), or ETV consistently for ≥12 months prior to dosing Day 1 - HBV DNA

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

50 Years

Здоровые волонтеры:

No
Общий контакт

Фамилия: Arbutus Biopharma

Телефон: 267-469-0914
Расположение
Объект: Положение дел: Контакт: Исследователь:
Research and Education, Inc. | San Diego, California, 92105, United States Recruiting Tuan Nguyen Tuan Nguyen Principal Investigator
University of Miami Miller School of Medicine | Miami, Florida, 33136, United States Recruiting Kaylan Bhamidimarri, MD Kaylan Bhamidimarri Principal Investigator
ID Care | Hillsborough, New Jersey, 08844, United States Recruiting Ronald Nahass, MD Ronald Nahass, MD Principal Investigator
Nepean Hospital | Kingswood, New South Wales, 2747, Australia Recruiting Martin Weltman Martin Weltman Principal Investigator
St Vincent's Hospital Melbourne | Melbourne, Victoria, 3065, Australia Recruiting Jacinta Holmes Jacinta Holmes Principal Investigator
Queen Mary Hospital | Hong Kong, Hong Kong Recruiting Man Fung Yuen Man Fung Yuen Principal Investigator
Arensia Exploratory Medicine Moldova | Chisinau, 2025, Moldova, Republic of Recruiting Tatiana Burda Tatiana Burda Principal Investigator
Chung-Ho Memorial Hospital | Kaohsiung, 83301, Taiwan Recruiting Wan-Long Chuang Wan-Long Chuang Principal Investigator
Medical Center of Limited Liability Company Harmoniya Krasy | Kyiv, 01135, Ukraine Recruiting Marta Dobryanska Marta Dobryanska Principal Investigator
Расположение Страны

Australia

Hong Kong

Moldova, Republic of

Taiwan

Ukraine

United States
Дата проверки

2022-01-01
Ответственная сторона

Тип: Sponsor

Ключевые слова
  • Hepatitis B virus
  • Chronic hepatitis B
  • HBV
  • Hepatitis
  • CHB
Имеет расширенный доступ No
Состояние Просмотр
  • Hepatitis A
  • Hepatitis B
  • Hepatitis B, Chronic
  • Hepatitis
  • Hepatitis, Chronic
Количество рук 4
Группа вооружений

Метка: Cohort A, Group 1

Тип: Experimental

Описание: AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Метка: Cohort A, Group 2

Тип: Experimental

Описание: AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 24 weeks.

Метка: Cohort B, Group 1

Тип: Experimental

Описание: AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: AB-729 60 mg SC every 8 weeks + NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Метка: Cohort B, Group 2

Тип: Experimental

Описание: AB-729 60 mg SC every 8 weeks + NA for 24 weeks, then randomized to: NA + Peg-IFNα-2a 180 mcg SC every week for 12 weeks.

Данные пациента No
Информация о дизайне исследования

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: None (Open Label)