Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence of death of patients infected with HDV during 5-year follow-up
研究概览
简要总结
This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma [hcc], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study.
It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF).
Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 or above, both sex;
- •Evidence of a positive test for HDV RNA can be provided on or before the enrollment date;
- •Able to sign written informed consent.
排除标准
- 未提供
结局指标
主要结局
The incidence of death of patients infected with HDV during 5-year follow-up
时间窗: 5 years
HDV means hepatitis D virus
The incidence of liver transplantation of patients infected with HDV during 5-year follow-up
时间窗: 5 years
HDV means hepaitis D virus
The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up
时间窗: 5 years
HDV means hepaitis D virus
The incidence of liver decompensation of patients infected with HDV during 5-year follow-up
时间窗: 5 years
liver decompensation means ascites, variceal bleeding, or hepatic encephalopathy
The incidence of cirrhosis of patients infected with HDV during 5-year follow-up
时间窗: 5 years
Patients who developed cirrhosis in the absence of cirrhosis at baseline by liver biopsy or noninvasive testing
次要结局
- The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT(5 years)
- Changes in serum HDV RNA during treatment and after discontinuation(5 years)
- Serum alanine aminotransferase concentration levels of patients infected with HDV(5 years)
- Demographic characteristics of HDV-infected individuals using baseline data(1 year)
- Serum HDV RNA levels of patients infected with HDV(5 years)
- Serum HBV DNA levels of patients infected with HDV(5 years)
- HBsAg concentration levels of patients infected with HDV(5 years)
- The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT(5 years)
- Epidemiological characteristics of HDV-infected individuals using baseline data(1 year)
- Serum total bilirubin concentration levels of patients infected with HDV(5 years)
- Combined response rate of patients with antiviral therapy(5 years)
- Serum albumin levels concentration levels of patients infected with HDV(5 years)
- The incidence of death of chronic HDV-infected patients with persistently normal ALT(5 years)
- The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT(5 years)
- The proportion of patients with HDV RNA negative conversion of patients receiving antiviral therapies(5 years)
- The proportion of patients with a >2lg IU/mL HDV RNA decline of patients receiving antiviral therapies(5 years)
- The proportion of patients with ALT normalization of patients receiving antiviral therapies(5 years)
- Child-Pugh scores of patients infected with HDV(5 years)
- The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT(5 years)
- Number of patients with abnormal laboratory values and/or adverse events that are related to antiviral treatment(5 years)
研究者
Lai Wei
Professor
Beijing Tsinghua Chang Gung Hospital