An Open Label Phase IV Multicenter Study for Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Patients With HBeAg Positive Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
研究概览
简要总结
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients, 18-65 years of age
- •HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
- •Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)
排除标准
- •Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
- •Evidence of decompensated liver disease
- •A medical condition associated with chronic liver disease other than viral hepatitis
研究组 & 干预措施
PEG-IFN alfa-2a (Treatment naïve)
Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
PEG-IFN alfa-2a (YMDD mutant)
Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72
时间窗: Week 72
Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.
Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72
时间窗: Week 72
Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.
次要结局
- Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72(Week 48 and Week 72)
- Percentage of Participants With ALT Normalization At Week 48 and Week 72(Week 48 and Week 72)
- Number of Participants With Any Adverse Events and Any Serious Adverse Events(Up to Week 72)
- Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72(Week 48 and Week 72)
- Percentage of Participants With a Combined Response At Week 48 and Week 72(Week 48 and Week 72)
- Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion(Week 48 and Week 72)
- Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72(Week 48 and Week 72)