Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- The proportion of indicated-but-not-treated CHB patients.
研究概览
简要总结
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Positive HBV surface antigen (HBsAg) for 6 months or more;
- •Elevated ALT levels (>1×ULN) and detectable HBV DNA;
- •Treatment-naïve;
- •Willing to attend this study and able to provide the written informed consent.
排除标准
- •Co-infection with other viral hepatitis and human immunodeficiency virus;
- •Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
- •Patients with liver cirrhosis;
- •Coexistence of hepatocellular carcinoma and other malignant tumor;
- •Underwent liver transplantation before the enrollment;
- •Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
结局指标
主要结局
The proportion of indicated-but-not-treated CHB patients.
时间窗: 18 months
The proportion of indicated-but-not-treated CHB patients.
次要结局
- The proportion of lost to follow-up in CHB patients.(18 months)
- The frequency of follow-up visit in CHB patients.(18 months)
研究者
Chao Wu
Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School