A Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
2020年3月6日 更新者：Yao Xie、Beijing Ditan Hospital
The Observational Cohort Study on Long-term Clinical Outcomes of Antiviral Therapy in Patients With Chronic Hepatitis B and Cirrhosis
This was a retrospective observational cohort study.
The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled.
Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study.
Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study.
HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment.
The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality.
Secondary evaluation index: the influence factors of different clinical outcomes.
To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
研究概览
详细说明
This was a retrospective observational cohort study.
The patients with chronic hepatitis B and cirrhosis who were treated with antiviral therapy in the Second Department of Liver Disease, Beijing Ditan Hospital, Capital Medical University from October 2008 to April 2020 were enrolled.
Patients treated with antiviral drugs including interferon and/or nucleoside (acid) analogues lasting more than 6 months were included in the study.
Interferon, nucleoside (acid) analogue monotherapy, combination therapy, sequential therapy, maintenance therapy and drug withdrawal therapy can all be included in the study.
HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe, biochemical indexes, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline), during treatment and after treatment.
The virological response and clinical outcome after antiviral treatment for chronic hepatitis B were observed for at least 288 weeks, and the main evaluation indicators were the occurrence or reversal of cirrhosis complications, hepatocellular carcinoma and mortality.
Secondary evaluation index: the influence factors of different clinical outcomes.
To investigate the long-term virological response and clinical outcome of antiviral therapy in patients with chronic hepatitis B and liver cirrhosis and to clarify its influencing factors.
研究类型
观察性的
注册 (预期的)
10000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
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Beijing、Beijing、中国、100015
- Department of Hepatology Division 2, Beijing Ditan Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Antiviral therapy for patients with chronic hepatitis B and cirrhosis.
Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
All patients with chronic hepatitis B and cirrhosis met the diagnostic criteria of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).
描述
Inclusion Criteria:
- Ages 18 to 75;
- Unlimited gender;
- Patients with chronic hepatitis B treated with interferon and / or nucleoside (acid) analogs (NA) antiviral therapy. All patients with chronic hepatitis B met the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)
- No hormones and / or immunosuppressants and other hepatoprotective drugs;
- Sign a written informed consent.
Exclusion Criteria:
- Combined with other hepatitis virus (HCV, 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
antiviral therapy group
Patients with chronic hepatitis B and cirrhosis were treated with antiviral drugs
|
Antiviral therapy for patients with chronic hepatitis B and cirrhosis.
Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The rate of incidence or reversal of cirrhosis comorbidities, liver cancer, and the incidence of death
大体时间：288 weeks after antiviral therapy
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The incidence or reversal of cirrhosis comorbidities, the incidence of liver cancer, and the incidence of death
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288 weeks after antiviral therapy
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2020年4月1日
初级完成 (预期的)
2021年4月1日
研究完成 (预期的)
2021年4月1日
研究注册日期
首次提交
2020年3月5日
首先提交符合 QC 标准的
2020年3月6日
首次发布 (实际的)
2020年3月10日
研究记录更新
最后更新发布 (实际的)
2020年3月10日
上次提交的符合 QC 标准的更新
2020年3月6日
最后验证
2020年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DTXY024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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