A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 219
- 主要终点
- Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
研究概览
简要总结
This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 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 patients, 18-65 years of age;
- •HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
- •absence of cirrhosis confirmed by liver biopsy in previous 12 months.
排除标准
- •previous treatment for chronic hepatitis B within previous 6 months;
- •antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
- •co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
- •history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
研究组 & 干预措施
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
2
干预措施: Entecavir (Drug)
2
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
3
干预措施: Entecavir (Drug)
3
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
时间窗: Week 72 for Arms 1 and 2. Week 92 for Arm 3.
次要结局
- AEs, laboratory parameters.(Throughout study)
- HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.(Week 72 for Arms 1 and 2. Week 92 for Arm 3.)