Observation Study on Reducing the Risk of Liver Cancer Associated With Hepatitis B (Zhiyuan) Project.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15,000
- 试验地点
- 162
- 主要终点
- Percentage of patients with HBsAg-associated HCC post-therapy
研究概览
简要总结
This study is a multicenter, prospective, observational real-world study designed to investigate and analyze the current treatment patterns of chronic hepatitis B (CHB) across 200 hospitals in China. By comparing patient outcomes under different therapeutic regimens, it aims to provide high-quality evidence-based medical data to optimize CHB treatment strategies and follow-up protocols, ultimately contributing to the advancement of a functional cure for chronic hepatitis B.
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
- •1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.
排除标准
- •1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).
研究组 & 干预措施
Group 1
干预措施: ETV,TDF,TAF,TMF (Drug)
Group 2
干预措施: Peginterferon α-2b injection (Drug)
结局指标
主要结局
Percentage of patients with HBsAg-associated HCC post-therapy
时间窗: Week 4-240
Hepatocellular Carcinoma (HCC) Incidence
时间窗: Week 4-240
次要结局
- Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV(Week 4-240)
- Rate of HBsAg seroclearance(Week 4-240)
- HBsAg seroconversion rate(Week 4-240)
- Number of patients with altered HBsAg levels post-treatment(Week 4-240)
- Number of patients with HBsAg level decline from baseline(Week 4-240)
- HBeAg seroconversion rate(Week 4-240)
- HBV DNA(Week 4-240)
- Liver fibrosis improvement rate(Week 4-240)
- Incidence of liver cirrhosis(Week 4-240)
- Incidence of decompensated cirrhosis(Week 4-240)
- Incidence of decompensation-related complications(Week 4-240)
- Liver transplantation incidence rate(Week 4-240)
- Post-treatment relapse rate(Week 4-240)
研究者
Hongxia Liang
Chief physician
The First Affiliated Hospital of Zhengzhou University