Therapeutic Option for Hepatitis B and C: a French Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,902
- 主要终点
- There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.
研究概览
简要总结
- The cohort will integrate clinical, genetic, pharmacogenomics, environmental, biomarkers and behavioral data in a large number of patients and will be a leading equipment for crossdisciplinary and translational research on hepatitis.
- The cohort will be the main support for estimating the relative effects of treatments and for further cost-effectiveness studies on the management and treatment options in chronic HCV (Hepatitis C Virus)and HBV (Hepatitis B virus)infections.
详细描述
General schedule of the study :
- Prospective multicenter national study
- Duration of inclusions:3 years
- Effective : 25000 patients
- Duration of the follow-up: 7-8 years
- Duration of the cohort: 10 years
Population :
Twenty-five thousands of people will be included and followed in investigator sites, 15000 with an hepatitis C and 10000 with an hepatitis B, according their usual follow-up of their liver disease.
We aim to include up to 50% patients naive of any HCV treatment at inclusion. Also HBV "cured" patients could be included (less than 10%).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •HBV-positive patients
- •Chronic hepatitis B defined by a positive HBsAg ( surface antigen of the hepatitis B virus) for at least 6 months
- •Acute hepatitis B defined as a recent appearance (<6 months) of detectable HBs Ag,
- •Chronic hepatitis B with serological remission HbsAg-negative , HB DNA-negative,
- •With or without association with acute or chronic hepatitis D.
- •HCV-positive patients
- •Chronic hepatitis C defined by the positivity for anti-HCV antibodies for at least 6 months and positive HCV-RNA
- •Acute hepatitis C defined by the recent appearance of HCV RNA (less than 6 months) in patients with risk factors (with or without positive antibodies)
- •Patients with cured hepatitis C defined by long-term eradication, either spontaneous, a positive anti-HCV antibodies associated to a negative RNA at two collection - 6 months interval time; either treatment defined by negative viremia 3 month after end of treatment.
排除标准
- •HIV co-infected patients are not eligible to the cohort.
- •So-called vulnerable populations (minors, people under guardianship or protection, or a private individual under protection from making legal or administrative decisions)
- •Treatment ongoing hepatitis C during or stopped since less than 3 months
- •Patients end of life
- •Woman whose pregnancy is known
结局指标
主要结局
There is no specific primary outcome measure but we indicated below (see Description) a list of potential outcome measures according to the objectives.
时间窗: From recruitment to the end of the cohort, with a minimum of one medical visit per year (the duration of follow-up is 7-8 years)
* Effectiveness of HCV or HBV treatments: Virological response, seroconversion, loss of agHbS, liver fibrosis or clinical response (including quality of life), safety. * Prognostic factors of HCV or HBV infection: liver fibrosis, cirrhosis, clinical or biological event. * Biomarker studies: Virological response, seroconversion, loss of agHbS, liver fibrosis, clinical or biological event, safety * Cost-effectiveness studies: cost perYLS, cost per QALY
次要结局
未报告次要终点