A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 255
- 主要终点
- HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
研究概览
简要总结
This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 participants 18-65 years of age
- •Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
- •Receiving lamivudine currently, and for >=6 months
- •hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
- •Absence of cirrhosis confirmed by liver biopsy in previous 6 months
排除标准
- •Other drugs with activity against HBV within the prior 6 months, except lamivudine
- •Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
- •Decompensated liver disease
- •Medical condition associated with another chronic liver disease
研究组 & 干预措施
ADV + Lamivudine
Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
干预措施: Adefovir dipivoxil (Drug)
ADV + Lamivudine
Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
干预措施: Lamivudine (Drug)
Peginterferon alfa-2a + Lamivudine
Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
干预措施: Lamivudine (Drug)
Peginterferon alfa-2a + Lamivudine
Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
时间窗: Week 72
次要结局
- Alanine transaminase (ALT) normalization(Week 48, and 72)
- Hepatitis B surface antigen (HBsAg) seroconversion(Week 48, and 72)
- Loss of HBeAg(Week 48, and 72)
- Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)(Week 48, and 72)