跳至主要内容
临床试验/NCT02344498
NCT02344498进行中(未招募)不适用

Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 7,350 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
7,350
试验地点
1
主要终点
Death, HCC or decompensated cirrhosis

研究概览

简要总结

Viral hepatitis kills nearly one million people each year, even though effective treatment exists. The aim of this study is to establish a treatment protocol for hepatitis B, which is simple and cheap enough to be implemented in resource-limited settings.

详细描述

Chronic viral hepatitis is a major health problem globally. Each year nearly one million deaths are attributable to either hepatitis B or C. In Ethiopia 5-10% of the general population are infected with hepatitis B. Oral antiviral treatment of hepatitis B exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of HIV/AIDS a decade ago.

The present study will investigate a simplified approach to hepatitis B treatment in resource-limited settings, inspired by the recent success of HIV treatment in such settings. The critical research question is how to identify patients with expected benefit of treatment in the absence of advanced laboratory support. A WHO expert panel recently suggested treatment criteria for use in settings without advanced laboratory facilities, but these criteria have not yet been tested out in real life. The present study will build on and develop the WHO approach to treatment of hepatitis B, aiming to develop a treatment protocol that can be feasible in other resource-limited countries. The potential public health benefit for poor people in low- and middle-income countries is substantial.

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

入选标准

  • Consenting adults (≥18 years) residing in Ethiopia who are HBsAg positive

排除标准

  • Children <18 years, other terminal disease (cancer etc.)

研究组 & 干预措施

Urban

HBV patients in Addis Abeba. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.

干预措施: Tenofovir disoproxil (Drug)

Rural

HBV patients in Adama, Afar, Jigjiga and Jimma. Eligible patients treated with tenofovir disoproxil fumarate 245 mg OD.

干预措施: Tenofovir disoproxil (Drug)

结局指标

主要结局

Death, HCC or decompensated cirrhosis

时间窗: 3 years

Patients will be reviewed every 3-6 months with liver function tests and/or ultrasound to detect the proportion of participants who develop liver decompensation or hepatocellular carcinoma.

次要结局

  • Adherence to therapy(3 years)
  • Viral suppression and genotypic resistance(3 years)
  • Regression of liver inflammation/fibrosis(3 years)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asgeir Johannessen

Researcher / project manager

Oslo University Hospital

研究点 (1)

Loading locations...

相似试验