Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,079
- 试验地点
- 2
- 主要终点
- Incidence of HCC or decompensated cirrhosis
研究概览
简要总结
The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps required to successfully treat patients with chronic hepatitis B virus infection to prevent cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B using a point of care test is feasible and effective. The second is to monitor linkage from screening into care. The third is to evaluate cheap non-invasive assessments to determine the need for treatment. The fourth is to determine what proportion of patients meet treatment eligibility criteria. The fifth step is to establish a treatment cohort which can be used to measure adherence to therapy and avoidance of HBV related complications. A parallel untreated cohort will be established to determine whether treatment criteria are relevant in this West African setting by monitoring for complications of HBV infection.
详细描述
Objectives Primary:
To determine whether suppression of HBV with a nucleotide analogue reduces the risk of liver cancer in West African populations.
Secondary:
To demonstrate that HBV replication can be effectively suppressed with a nucleotide analogue in West African populations To evaluate whether European treatment guidelines are applicable in West Africa To establish the applicability and efficacy of population based screening, clinical assessment and treatment in West Africa To enumerate the proportion of the adult population who carry HBV To evaluate the proportion of the HBV infected population who meet European Association for Study of the Liver (EASL) criteria for treatment
Endpoints Primary:
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
- •Adult Informed consent HBsAg positive Resident in Gambia or Senegal
排除标准
- •HIV infection HCV infection Known liver cancer
研究组 & 干预措施
Treatment Group (Tenofovir disoproxil)
Patients who meet EASL treatment criteria who receive Tenofovir disoproxil
干预措施: Tenofovir disoproxil (Drug)
结局指标
主要结局
Incidence of HCC or decompensated cirrhosis
时间窗: 5 years
Subjects will be reviewed 6 monthly with liver biochemistry and ultrasound to detect onset of hepatocellular carcinoma or decompensated cirrhosis
次要结局
- Uptake of screening(2 years)
- Rate of linkage into care(2 years)
- Prevalence of HBV infection(2 years)
- Treatment rate(2 years)