Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 515
- 试验地点
- 36
- 主要终点
- Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
研究概览
简要总结
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.
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
- •HBsAg-positive subjects
- •18 years or older
- •anti-HD-positive
排除标准
- 未提供
结局指标
主要结局
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Serum HBV DNA levels in HDV-infected patients
时间窗: 1 year
HBV means hepatitis B virus. HDV means hepatitis D virus
Liver stiffness values in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Demographic characteristics of HDV-infected patients
时间窗: 1 year
Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
Serum alanine aminotransferase concentration values in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Epidemiologic characteristics of HDV-infected patients
时间窗: 1 year
Risk factors for infection. HDV means hepatitis D virus
Blood platelet count in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Serum albumin concentration values in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Serum total bilirubin concentration values in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
时间窗: 1 year
HDV means hepatitis D virus
Serum HDV RNA levels in HDV-infected patients
时间窗: 1 year
HDV means hepatitis D virus
Proportion of HDV genotypes among patients with detectable HDV RNA
时间窗: 1 year
HDV means hepatitis D virus
HBsAg concentration levels in HDV-infected patients
时间窗: 1 year
HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
时间窗: 1 year
HDV means hepatitis D virus
Proportion of patients treated with antiviral therapy among seropositive anti-HDV
时间窗: 1 year
HDV means hepatitis D virus
Proportion of patients with detectable HBV DNA among seropositive anti-HDV
时间窗: 1 year
HBV means hepatitis B virus. HDV means hepatitis D virus
Proportion of HBV genotypes among patients with detectable HBV DNA
时间窗: 1 year
HBV means hepatitis B virus
Proportion of patients with liver cirrhosis among seropositive anti-HDV
时间窗: 1 year
HDV means hepatitis D virus
HBcrAg concentration levels in HDV-infected patients
时间窗: 1 year
HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
次要结局
未报告次要终点