A Follow-up Study to Evaluate the One-year Post Treatment Effects of Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study ML 22265

Hoffmann-La Roche0 个研究点目标入组 65 人开始时间: 2011年4月最近更新: 2016年11月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 65
主要终点: Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.

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

•Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point

排除标准

•Patients unwilling to provide informed consent or abide by the requirements of the study

结局指标

主要结局

Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment

时间窗: 1 year

次要结局

Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT)(1 year)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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