An Observational Cohort Study of Clinical Outcomes After Antiviral Treatment of Chronic Hepatitis C Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of liver cancer
研究概览
简要总结
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. In the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, chronic hepatitis C patients who were treated with interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ), and the baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment were collected, and follow-up observations of patients were carried out for every 3-6 months. The clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) were collected during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
详细描述
This study is a two-way, non-interventional long-term dynamic follow-up clinical observational cohort study. Enrolled in the Second Division of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, via interferon combined with ribavirin (PR) antiviral therapy (PR treatment for 6 months or more) and / or direct acting antivirals (DAAs ) For patients with chronic hepatitis C treated, collect baseline, antiviral treatment and discontinuation follow-up data of patients before antiviral treatment, and follow-up observations of patients enrolled every 3-6 months. Collect clinical data such as clinical biochemistry, HCV RNA and serological indicators (anti-HCV), AFP, and liver imaging (liver ultrasound) during the study period. The virological response and clinical outcomes of chronic hepatitis C antiviral therapy were observed for at least 144 weeks. The incidence of liver cancer and decompensated liver cirrhosis after discontinuation of the drug was the main evaluation index. The aim is to explore long-term virological response and clinical outcomes, and elucidate its influencing factors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 75;
- •Unlimited gender;
- •Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy for 6 months or more) and / or direct antiviral drugs (DAAs). All patients with chronic hepatitis C met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis C (2015)
- •No hormones and / or immunosuppressants and other hepatoprotective drugs;
- •Sign a written informed consent.
排除标准
- •Combined with other hepatitis virus (HBV, HDV) infections;
- •Immune liver disease;
- •HIV infection;
- •long-term alcohol and / or other liver damage drugs;
- •mental illness;
- •Evidence of liver tumor (liver cancer or AFP> 100 ng / ml);
- •Decompensated cirrhosis;
- •Those who have serious heart, brain, lung, kidney and other system diseases that cannot participate in long-term follow-up;
- •There are hormones and / or immunosuppressants and other hepatoprotective drugs.
研究组 & 干预措施
interferon combined with ribavirin (PR) antiviral therapy
Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
干预措施: interferon combined with ribavirin (PR) antiviral therapy (Drug)
direct antiviral drugs (DAAs)
Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)
干预措施: direct antiviral drugs (DAAs) (Drug)
结局指标
主要结局
Incidence of liver cancer
时间窗: 144 weeks after withdrawal
Incidence of liver cancer after chronic hepatitis C antiviral treatment
Incidence of decompensated cirrhosis
时间窗: 144 weeks after withdrawal
Incidence of decompensated cirrhosis after chronic hepatitis C antiviral treatment
次要结局
- Rate of sustained virological response or relapse(144 weeks after withdrawal)
研究者
Yao Xie
Director of Hepatology Division 2
Beijing Ditan Hospital