NCT01760122已完成3 期
A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 820
- 试验地点
- 43
- 主要终点
- Proportion of patients with HBeAg seroconversion at week72
研究概览
简要总结
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
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
- •Age: 18~65 years.
- •Serum HBsAg or HBV DNA positive for at least 6 months.
- •Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
- •2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
- •Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.
排除标准
- •Pregnant or lactating women.
- •Mental disorder or physical disability.
- •Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- •ANC < 1500/mm3, or PLT < 90,000/mm
- •Co-infection with HAV, HIV, HCV, HDV, or HEV.
- •Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
- •Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
- •Chronic hepatitis caused by any other reason except hepatitis B.
- •Hepatocarcinoma or suffering from any other malignant tumor.
- •Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
- •Significant function damage in any major organs (e.g.: heart, lung, kidney).
- •Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
研究组 & 干预措施
Ypeginterferon Alfa-2b
Experimental
干预措施: Ypeginterferon alfa-2b (Drug)
Pegasys
Active Comparator
干预措施: Pegasys (Drug)
结局指标
主要结局
Proportion of patients with HBeAg seroconversion at week72
时间窗: 24 weeks after the cessation of treatment
次要结局
- Average of HBV DNA decline level at week 12, 24,48 and 72(week 12, 24, 48 and 72 from treatment starting)
- Proportion of patients with ALT normalization at week 12,24, 48 and 72.(week 12, 24, 48 and 72 from treatment starting)
- Proportion of Patients with HBeAg seroconversion at week 12,24,48(week 12, 24, 48 from treatment starting)
- Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.(week 4, 12, 24, 48 and 72 from treatment starting)
- Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.(week 12, 24, 48 and 72 from treatment starting)
研究者
研究点 (43)
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