跳至主要内容
临床试验/NCT02863757
NCT02863757招募中不适用

Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Humanity and Health Research Centre1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
1
主要终点
Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma

研究概览

简要总结

The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Liver biopsy proved CHB and/or NAFLD at baseline;
  • •Follow-up duration>12 months

排除标准

  • •Other liver diseases;
  • •Secondary causes of hepatic steatosis;
  • •Alcohol abuse;
  • •Liver cirrhosis, cirrhosis related complications or HCC at baseline;
  • •Malignancy;
  • •History of liver transplantation

研究组 & 干预措施

CHB Group

Patients with chronic hepatitis B

CHB/NAFLD Group

Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease

NAFLD Group

Patients with nonalcoholic fatty liver disease

结局指标

主要结局

Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma

时间窗: Up to 20 years

次要结局

  • Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia(Up to 20 years)
  • Number of patients with liver transplantation and liver-related death(Up to 20 years)
  • Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline(Up to 20 years)
  • Occurrence time of liver transplantation and liver-related death from baseline(Up to 20 years)

研究者

发起方
Humanity and Health Research Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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