Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 试验地点
- 10
- 主要终点
- Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
研究概览
简要总结
The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B.
Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.
详细描述
This study is a prospective, exploratory, multi-center, real-world study, with Huashan Hospital as the leading unit. The study includes patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment { including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy. The study only collects clinical data and serum samples, without imposing any additional intervention measures or affecting any relevant clinical decisions. The clinical data is collected from the patient's clinical follow-up examination data, without additional visits and auxiliary examinations. Sample collection During the necessary clinical examination and blood draw during the patient's treatment and follow-up, one additional serum separation tube (3ml) was drawn, without additional invasive examination for the patient. The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;
- •Age between 18-80 years, gender is not limited；
- •Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon [IFN] monotherapy, a potent nucleos(t)ide analogue [NA] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy;
- •Patient who reads and signs informed consent.
排除标准
- •Patients with malignancies other than hepatocellular carcinoma.
研究组 & 干预措施
Chronic hepatitis B patients treated with nucleoside analogues or interferon
Chronic hepatitis B patients treated with nucleoside analogues or interferon
干预措施: nucleoside analogues or interferon (Drug)
结局指标
主要结局
Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
时间窗: 5 years
Number of Participants with Diagnosis of hepatocellular carcinoma
次要结局
- Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period(Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240)
- Number of Participants with Diagnosis of participants with liver transplantation during the observation period(Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240)
- Number of Participants with Diagnosis of participants with serological response during the observation period(Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240)
- Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period(Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240)
研究者
Wen-hong Zhang
Director of Division ofInfectious Diseases Affiliation: Huashan Hospital
Huashan Hospital