NCT03181113已完成不适用
A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 473
- 试验地点
- 28
- 主要终点
- rate of HBeAg seroconversion
研究概览
简要总结
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and sign the informed consent form.
- •Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.
排除标准
- •Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).
研究组 & 干预措施
peginterferon alfa 2b
干预措施: Peginterferon Alfa-2B (Drug)
peginterferon alfa 2a
干预措施: Peginterferon Alfa-2A (Drug)
结局指标
主要结局
rate of HBeAg seroconversion
时间窗: from the second year to the fifth year
次要结局
- decent degree of HBV DNA(from the second year to the fifth year)
- decent degree of HBeAg(from the second year to the fifth year)
- rate of alanine aminotransferase normalization(from the second year to the fifth year)
- rate of HBeAg loss(from the second year to the fifth year)
- rate of HBeAg seroconversion(from the second year to the fifth year)
- rate of HBV DNA undetectable(from the second year to the fifth year)
研究者
研究点 (28)
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