Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
研究概览
简要总结
Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.
详细描述
Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •HBV-infected, defined as any single positive HBsAg assay
排除标准
- •Unable or unwilling to provide informed consent
- •HIV-positive
结局指标
主要结局
Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients)
时间窗: Baseline and after 1 year of treatment
The percentage of patients with HBV viral suppression.
次要结局
- Proportion of chronic HBV-infected patients with an indication for antiviral treatment.(baseline, after 1 year of treatment, after 2 years of treatment)
- HBV viral control among patients on antiviral treatment(baseline, after 1 year of treatment, after 2 years of treatment)
- Proportion with significant liver fibrosis(0, 12, 24, 36, 48, and 60 months,)
- Incidence and prevalence of hepatocellular carcinoma (HCC)(baseline and after month 60)
- Serologic, virologic, and hepatic features of chronic HBV infection in Zambia(0 to month 60)
研究者
Michael Vinikoor
Professor of Medicine
University of Alabama at Birmingham