NCT01734018已完成不适用
A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
研究概览
简要总结
This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.
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
- •Adult patients, >/= 18 years of age
- •HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
- •Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label
排除标准
- •Contra-indications to Pegasys as detailed in the label
- •Co-infection with hepatitis A, hepatitis B or HIV
- •Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
- •Pregnant or breastfeeding women
结局指标
主要结局
Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
时间窗: from baseline to up to approximately 3 years
Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up
时间窗: from baseline to up to approximately 3 years
次要结局
- Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)(approximately 4 years)
- Percentage of patients with normalisation of serum alanine transaminase (ALT) levels(approximately 4 years)
- Percentage of patients with HBsAg clearance/seroconversion(approximately 4 years)
- Safety: Incidence of adverse events(approximately 4 years)
研究者
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