The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- HBeAg sericonversion rate
研究概览
简要总结
For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
详细描述
For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years old
- •HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
- •Treated by entacavir for 48 weeks with HBeAg seroconversion
排除标准
- •Pregnant women
- •Decompensated liver disease
- •Combination infection of HCV, HAV, or HEV
- •Combination infection of HIV
- •Any contraindication of interferon α
研究组 & 干预措施
entecavir
patients continue to use entecavir
干预措施: Entecavir (Drug)
peg-interferon
patients switch to sequential peg-interferon α-2a
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
HBeAg sericonversion rate
时间窗: 72 weeks
次要结局
- HBeAg loss rate(72 weeks)
- HBeAg quantification dynamic change(72 weeks)
- HBsAg loss rate(72 weeks)
- HBsAg seroconversion rate(72 weeks)
- HBsAg quantification dynamic change(72 weeks)
- ALT normalization rate(72 weeks)
研究者
Gao zhiliang
professor
Sun Yat-sen University