A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 978
- 试验地点
- 88
- 主要终点
- Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
研究概览
简要总结
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.
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 participants, >/= 18 years of age
- •Treatment with Pegasys according to label and standard clinical practice
- •HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
- •Serum alanine aminotransferase (ALT) > upper limit of normal (ULN) but </= 10 x ULN
- •Hepatitis B Virus (HBV) DNA >/= 2000 IU/mL
排除标准
- •Contraindications to Pegasys as detailed in the label
- •Co-infection with hepatitis A, hepatitis C or HIV
- •Pregnant or lactating women
- •Participants should not receive concomitant therapy with telbivudine
研究组 & 干预措施
Chronic Hepatitis B Participants
Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.
干预措施: Pegylated Interferon Alfa (Peginterferon Alfa) (Drug)
结局指标
主要结局
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
时间窗: approximately 4 years
次要结局
- Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment(approximately 4 years)
- Incidence of normalization of serum ALT levels(approximately 4 years)
- Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment(approximately 4 years)
- Incidence of HBsAg loss/seroconversion(approximately 4 years)
- Dosage/schedule of Pegasys treatment in real-life clinical setting(approximately 4 years)
- Clinical/demographic patient characteristics at initiation of treatment(approximately 4 years)
- Safety: Incidence of adverse events(approximately 4 years)