National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
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: Blood draw for the laboratory assessment.
- Кому может быть актуально
- Состояния в реестре: Hepatitis D, Chronic, Hepatitis B, Chronic. Базовые параметры: от 18 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
Подробное описание
This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:
* Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months; * Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.
Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable:
* Samples for the biobank, * Self-administered questionnaires.
In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
Вмешательства
- Другое Blood draw for the laboratory assessment
Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.
Первичные конечные точки
- To study the natural or treated history of patients infected with HDV according to different management modalities. [Срок оценки: At the end of the follow-up, december 2027]
Вторичные конечные точки (12)
- Number of patient's reported outcomes measured with specific questionnaire [Срок оценки: weeks 24, 48, end of treatment and 48 weeks after the end of treatment]
- Quality of observance measured with specific questionnaire [Срок оценки: weeks 24, 48, end of treatment and 48 weeks after the end of treatment]
- Alcohol consumption (AUDIT-c), tobacco and cannabis use [Срок оценки: weeks 24, 48, end of treatment and 48 weeks after the end of treatment]
- Socio-economic situation measured with specific questionnaire [Срок оценки: weeks 24, 48, end of treatment and 48 weeks after the end of treatment]
- Quality of life level measured with short-form 12 (SF12) questionnaire [Срок оценки: At weeks 24, 48, end of treatment and 48 weeks after the end of treatment]
- Rate of patients achieving HBV DNA indetectability [Срок оценки: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)]
- Rate of early discontinuation of treatment due to an adverse event [Срок оценки: At weeks 12, 24, 48, end of treatment]
- HDV RNA level [Срок оценки: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)]
- HDV RNA variation rate [Срок оценки: At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)]
- Breakthrough rate [Срок оценки: At weeks 8, 12 and through the end of treatment (average 3 years)]
- Rate of sustained virological response [Срок оценки: At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)]
- Rate of partial virological response [Срок оценки: At weeks 4, 8, 12 and through the end of treatment (average 3 years)]
Критерии участия
Критерии включения
- Age > 18 years,
- Presenting a chronic HDV infection (positive serology),
- Who gave his written informed consent before any intervention and the day of inclusion at the latest,
- Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).
Критерии исключения
- Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
- Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
- Patients with predictable difficulties of follow-up according to the investigator.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 38 центров
- CHU of Angers — Angers
- Centre Hospitalier de la région annécienne — Annecy
- Avicenne Hospital - Hepatology — Bobigny
- Avicenne Hospital — Bobigny
- Haut Lévêque Hospital — Bordeaux
- Estaing Hospital — Clermont-Ferrand
- Beaujon Hospital — Clichy
- Centre Hospitalier Intercommunal — Créteil
- … и ещё 30 центров
Идентификаторы
NCT: NCT04166266 · ANRS HD EP01-HEPDELTA