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Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

2021年10月7日 更新者：Hong You、Beijing Friendship Hospital

Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy

In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.

研究类型

观察性的

注册 (预期的)

600

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。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Beijing
      • Beijing、Beijing、中国、100050
        • Beijing Friendship hospital, Capital Medical University
        • 首席研究员：
          • Hong You, Doctor
        • 接触：
        • 接触：
      • Beijing、Beijing、中国、10069
        • Beijing Youan Hospital, Capital Medical University
        • 接触：
        • 首席研究员：
          • Zhongjie Hu
    • Hunan
      • Changsha、Hunan、中国、410011
        • Xiangya Hospital Central South University
        • 接触：
    • Inner Mongolia
      • Baotou、Inner Mongolia、中国
        • The Second Affiliated Hospital of Baotou Medical Coll
    • Shandong
      • Jinan、Shandong、中国、250021
        • Shandong Provincial Hospital
        • 接触：
        • 首席研究员：
          • Chunqing Zhang, Docote
      • Qingdao、Shandong、中国、266000
        • The Affiliated Hospital of Qingdao University
        • 接触：
        • 首席研究员：
          • Wei Rao, Docotr
    • Shanxi
      • Taiyuan、Shanxi、中国、030001
        • First Hospital of Shanxi Medical University
        • 接触：
        • 首席研究员：
          • Yanqin Hao, Doctor
        • 首席研究员：
          • Liaoyun Zhang, Doctor

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

  • 孩子
  • 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

概率样本

研究人群

HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.

描述

Inclusion Criteria:

  1. Ascites and/or variceal hemorrhage (VH) as the first decompensated events;
  2. Initiating antiviral therapy within 3 months of the first decompensated events;
  3. Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,

  4. Clinical outcomes were classified:

    1. Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
    2. With ≥ 2 episodes of decompensation: medical records for decompensation were available.

Exclusion Criteria:

  1. Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
  2. Liver transplantation /death within 6 months of first decompensated events;
  3. complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
  4. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
  5. Pregnant women.

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

队列和干预

团体/队列
干预/治疗
early stage decompensation cohort
Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included.
其他：no intervention
This is a retrospective and observational study.

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
Cumulative incidence of re-compensation
大体时间：Year 5
Patients who did not occur further decompensation
Year 5

次要结果测量

结果测量
措施说明
大体时间
Cumulative incidence of re-compensation
大体时间：Year 1, 2, 3, and 4
Patients who did not occur further decompensation
Year 1, 2, 3, and 4
Annual incidence of second decompensation
大体时间：Year 1, 2, 3, 4, and 5
Patients who occurred second decompensation
Year 1, 2, 3, 4, and 5
Cumulative incidence of liver-related death / liver transplantation
大体时间：Year 1, 2, 3, 4, and 5
Patients who died of decompensation
Year 1, 2, 3, 4, and 5
Cumulative incidence of HCC
大体时间：Year 1, 2, 3, 4, and 5
Patients who occurred HCC
Year 1, 2, 3, 4, and 5
Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group
大体时间：Year 1, 2, 3, 4, and 5
Child-Pugh
Year 1, 2, 3, 4, and 5
Dynamic changes of MELD score in re-compensated and not re-compensated group
大体时间：Year 1, 2, 3, 4, and 5
MELD
Year 1, 2, 3, 4, and 5
Dynamic changes of APRI score in re-compensated and not re-compensated group
大体时间：Year 1, 2, 3, 4, and 5
APRI
Year 1, 2, 3, 4, and 5
Dynamic changes of FIB-4 score in re-compensated and not re-compensated group
大体时间：Year 1, 2, 3, 4, and 5
FIB-4
Year 1, 2, 3, 4, and 5
Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group
大体时间：Year 1, 2, 3, 4, and 5
Liver stiffness
Year 1, 2, 3, 4, and 5

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。

赞助

Beijing Friendship Hospital

合作者

Xiangya Hospital of Central South University
Beijing YouAn Hospital
The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
The First Affiliated Hospital of Shanxi Medical University
The Second Affiliated Hospital of Baotou Medical College

调查人员

  • 首席研究员：Hong You, Doctor、Beijing Friendship Hospita

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2021年10月15日

初级完成 (预期的)

2022年6月1日

研究完成 (预期的)

2022年12月30日

研究注册日期

首次提交

2021年9月19日

首先提交符合 QC 标准的

2021年10月7日

首次发布 (实际的)

2021年10月21日

研究记录更新

最后更新发布 (实际的)

2021年10月21日

上次提交的符合 QC 标准的更新

2021年10月7日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2021-P2-224-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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