Cameroon Baptist Convention Health Board Chronic Hepatitis B Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- yearly incidence of compensated and decompensated cirrhosis in the study cohort
研究概览
简要总结
The natural history and response to therapy of chronic hepatitis B infection in West Africa are currently poorly understood. In this study, employees of the Cameroon Baptist Convention Health Board (CBCHB) and spouses who are found to be hepatitis B positive on screening will be offered enrollment. Disease monitoring and treatment will be provided following current WHO guidelines. Clinical data will be prospectively recorded for 5 years, and bio-specimens will be frozen for future analysis.
详细描述
Chronic hepatitis B (CHB) is common in Cameroon, and hepatitis B-related hepatocellular carcinoma is a leading cause of cancer death throughout West and Central Africa. Little is known about the natural history of CHB in sub-Saharan Africa and the long term response to antiviral therapy. The study hypothesis is that these can be determined by prospective follow-up of a population-based cohort.
Aims, purpose, or objectives:
- To determine the characteristics of a population of asymptomatic Cameroonian adults who work for the Cameroon Baptist Convention Health Board (CBCHB) who have chronic hepatitis B infection.
- To determine the phase of infection into which these Hepatitis B carriers fall.
- To determine the incidence and risk factors for cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma in this cohort over time.
- To offer treatment according to a standardized protocol, and to determine the outcome of treatment.
- To archive serum samples from patients for potential future studies of specific markers associated with hepatitis B and liver disease outcomes.
Methods: Adult employees of the Cameroon Baptist Convention Health Board (CBCHB) and their spouses who are known to be positive for hepatitis B surface antigen (HBsAg+) will be offered the enrollment in a cohort study for CHB. Following enrollment, their stage of disease will be determined using clinical, laboratory and imaging studies. Patients will then be followed at regular intervals for 5 years. Antiviral therapy will be offered to patients who qualify according to current World Health Organization guidelines.
Significance: This protocol will prospectively determine the scope of CHB-related illness in an initially asymptomatic, population-based cohort and the outcomes of current WHO treatment guidelines in this African cohort.
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
- •Age at least 18yrs.
- •CBCHB employee or spouse of an employee.
- •Able to provide written informed consent.
- •Willing to comply with follow-up visits.
排除标准
- 未提供
结局指标
主要结局
yearly incidence of compensated and decompensated cirrhosis in the study cohort
时间窗: 5 years
incidence of compensated and decompensated cirrhosis over time in the study cohort, as determined by interval history, physical exam, APRI (AST to platelet ratio index), and ultrasound findings
Proportion of subjects in each phase of chronic hepatitis B infection at enrollment
时间窗: Enrollment
distribution of subjects across the 4 phases of chronic hepatitis B at enrollment (immune tolerant, immune clearance, inactive carrier, and reactivation phases). This is determined by enrollment age, ALT, HBeAg status, clinical and imaging findings of cirrhosis, and (in some cases) serum hepatitis B DNA quantification
yearly incidence of hepatocellular carcinoma in the study cohort
时间窗: 5 years
incidence of hepatocellular carcinoma over time in the study cohort as determined by serum alpha fetoprotein, per-protocol imaging studies, and biopsy when appropriate
Percentage of treated subjects who achieve and maintain a complete response to antiviral treatment.
时间窗: 5 years
Percentage of subjects receiving antiviral treatment who achieve and maintain a complete response as determined by normalization of serum transaminases and (in some cases) loss of detectable serum hepatitis B DNA
次要结局
未报告次要终点
研究者
Lewis R. Roberts
Principal Investigator
Mayo Clinic