NCT04166266招募中不适用
National Cohort of Patients Co-infected with Hepatitis B and Delta Viruses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 38
- 主要终点
- To study the natural or treated history of patients infected with HDV according to different management modalities.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
To study the natural or treated history of patients infected with HDV according to different management modalities.
时间窗: At the end of the follow-up, december 2027
This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.
次要结局
- Number of patient's reported outcomes measured with specific questionnaire(weeks 24, 48, end of treatment and 48 weeks after the end of treatment)
- Quality of observance measured with specific questionnaire(weeks 24, 48, end of treatment and 48 weeks after the end of treatment)
- Alcohol consumption (AUDIT-c), tobacco and cannabis use(weeks 24, 48, end of treatment and 48 weeks after the end of treatment)
- Socio-economic situation measured with specific questionnaire(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(At weeks 24, 48, end of treatment and 48 weeks after the end of treatment)
- Rate of patients achieving HBV DNA indetectability(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(At weeks 12, 24, 48, end of treatment)
- HDV RNA level(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(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(At weeks 8, 12 and through the end of treatment (average 3 years))
- Rate of sustained virological response(At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years))
- Rate of partial virological response(At weeks 4, 8, 12 and through the end of treatment (average 3 years))
- Rate of patients achieving HBs seroconversion(At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027))
- Virological response delay(At weeks 8, 12 and through the end of treatment (average 3 years))
- Number of different HDV resistance variants(Through treatment period, average 3 years)
- Number of patients with at least one resistance variant(Through treatment period, average 3 years)
- Fibrosis level(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 adverse event(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))
- Death rate(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))
- Liver transplantation rate(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))
- Number and characterization of associated treatment with analogs and/or interferon(At weeks 4, 8, 12 and through the end of treatment (average 3 years)
- Rate of patients presenting an evolution towards hepatocellular carcinoma(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 patients presenting an evolution towards cirrhosis(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 patients presenting a decompensated cirrhosis(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))
- Change in HBs Ag from baseline(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 biochemical response(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 patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive(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 patients with appearance of anti-HBe Ab(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 patients achieving HBe seroconversion(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 spontaneous virological recovery(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 patients achieving HBs Ag negativation(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 patients with appearance of anti-HBs Ab(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))
研究者
研究点 (38)
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