NCT01243281Unknown不适用
A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
研究概览
简要总结
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy
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
- Single (Investigator)
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
- •Men and women 18 to 65 years of age
- •Patients with HBeAg-negative chronic hepatitis B
- •Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
- •Serum HBV DNA levels ≥ 2,000 IU/mL at screening
- •Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
- •No signs or symptoms of advanced liver disease
- •Patient has had a liver biopsy within 1 year of screening
排除标准
- •Patient had previous treatment with IFN, peg-IFN, and/or entecavir
- •Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
- •Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
- •Patients with liver cancer
- •Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
- •Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
- •Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug
研究组 & 干预措施
drug combination
Active Comparator
干预措施: PEG-IFN and entecavir (Drug)
结局指标
主要结局
To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B
时间窗: 24 weeks post treatment
次要结局
- To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment(24 weeks post treatment)
研究者
研究点 (1)
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