A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 265
- 主要终点
- Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
研究概览
简要总结
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
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 years of age
- •HBeAg positive chronic hepatitis B
- •Compensated liver disease
排除标准
- •Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
- •Antiviral, anti-neoplastic or immunomodulatory treatment
- •Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
- •Evidence of decompensated liver disease
- •Chronic liver disease other than viral hepatitis
研究组 & 干预措施
D
干预措施: peginterferon alfa-2a [PEGASYS] (Drug)
A
干预措施: peginterferon alfa-2a [PEGASYS] (Drug)
B
干预措施: peginterferon alfa-2a [PEGASYS] (Drug)
C
干预措施: peginterferon alfa-2a [PEGASYS] (Drug)
D
干预措施: Adefovir (Drug)
结局指标
主要结局
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
时间窗: Weeks 72, 96, 120
次要结局
- Safety: Adverse Events(From baseline to Week 120)
- Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml(Weeks 24, 48, 72, 96, 120)