Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Baracle Tab.®.
- Кому может быть актуально
- Состояния в реестре: Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug, HBV. Базовые параметры: 19 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Randomized, Prospective, Comparative Study of the Effectiveness of Prophylactic Entecavir Treatment for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Обзор
This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
Подробное описание
This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
In this study, patients are randomized into treatment group or delayed treatment group.
\* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.
1. Experimental: Treatment group (n=113) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after allogeneic hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
\* oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation. 2. No Intervention: delayed treatment group (n=113) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.
Вмешательства
- Препарат Baracle Tab.®
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Первичные конечные точки
- Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups. [Срок оценки: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation]
Вторичные конечные точки (3)
- Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. [Срок оценки: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.]
- Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups. [Срок оценки: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.]
- Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups. [Срок оценки: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.]
Критерии участия
- Inclusion Criteria:
- Age: 19 - 70
- Patients receiving allogeneic hematopoietic stem cell transplantation
- HBV serologic test: HBsAg (-), anti-HBc IgG (+) before receiving allogeneic hematopoietic stem cell transplantation
- ECOG performence: 0-2
- patients with informed consent
- Exclusion Criteria:
- HBV DNA (+, ≥10 IU/mL) at the time of screening
- Receiving hematopoietic stem cell transplantation from donor with HBsAg+
- Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
- HIV (+)
- Previous antiviral therapy history for chronic hepatitis B
- Other concomitant malignancy
- Combined autoimmune disease (rheumatic arthritis, SLE etc)
- CTP class B, C
- Decompensated complications (ascites, hepatic encephalopathy etc.)
- Active tuberculosis
- Patients with lymphoma
- Patients receiving autologous hematopoietic stem cell transplantation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
South Korea · 1 центр
- Jeong Won Jang — Seoul
Идентификаторы
NCT: NCT04942886 · KC20MISI0622