NCT07007286尚未招募不适用
A Real-World Study on Reducing the Risk of Liver Cancer in Chronic Hepatitis B Patients With a Family History of HBV-Related Liver Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 试验地点
- 554
- 主要终点
- 5-year incidence of hepatocellular carcinoma (HCC)
研究概览
简要总结
This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.
排除标准
- •(1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
PEG IFNα-2b Group
干预措施: ETV,TDF,TAF,TMF combination with PEG IFNα-2b (Drug)
Nucleos(t)ide Monotherapy Group
干预措施: ETV,TDF,TAF or TMF (Drug)
结局指标
主要结局
5-year incidence of hepatocellular carcinoma (HCC)
时间窗: From the start of antiviral treatment to 5 years of follow-up.
次要结局
- HBsAg seroclearance rate(From the start of antiviral treatment to 5 years of follow-up.)
- HBeAg seroclearance rate(From the start of antiviral treatment to 5 years of follow-up.)
- HBV DNA level(From the start of antiviral treatment to 5 years of follow-up.)
- HBsAg level(From the start of antiviral treatment to 5 years of follow-up.)
- HBeAg level(From the start of antiviral treatment to 5 years of follow-up.)
- Proportion of patients with improved or progressed liver fibrosis(From the start of antiviral treatment to 5 years of follow-up.)
- Median time to cirrhosis(From the start of antiviral treatment to 5 years of follow-up.)
- Median time to decompensated cirrhosis(From the start of antiviral treatment to 5 years of follow-up.)
- Median time to HCC(From the start of antiviral treatment to 5 years of follow-up.)
- Overall survival (OS)(From the start of antiviral treatment to 5 years of follow-up.)
研究者
Guiqiang Wang
Chief physician
Peking University First Hospital
研究点 (554)
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