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临床试验/NCT02005146
NCT02005146已完成不适用

Retrospective Observational Study to Define HBsAg Loss With or Without Seroconversion to antiHBs in Patients With Chronic Hepatitis by B Virus Treated With Nucleoside/Nucleotide Analogs

Fundación Pública Andaluza Progreso y Salud22 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
22
主要终点
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues

研究概览

简要总结

Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old
  • Chronic hepatitis B (HBeAg+ or HBeAg-)
  • HBsAg loss
  • Treated with nucleoside/nucleotide analogues
  • With or without previous interferon (IFN/PEG-IFN)
  • Patients with HBsAg loss after 2006
  • Immunocompetent patients

排除标准

  • Spontaneous HBsAg loss
  • HBsAg loss while treatment in monotherapy or combinated with IFN or PEG-IFN.
  • Patients with hepatitis delta virus (HDV) coinfection.
  • Patients with hepatitis C virus (HCV) coinfection.
  • Patients with HIV coinfection.
  • Patients with liver transplant.
  • Patients with reactivated hepatitis B virus (HBV) by immuno-suppressive treatment.

结局指标

主要结局

Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues

时间窗: 15 months

Study the number of diferents virological, serological, clinical, histological, biochemical characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues.

次要结局

  • Epidemiological characteristics in case of suspension of treatment.(15 months)

研究者

发起方
Fundación Pública Andaluza Progreso y Salud
申办方类型
Other
责任方
Sponsor

研究点 (22)

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