NCT00781105已完成4 期
An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 1
- 主要终点
- HBV DNA PCR negativity rate
研究概览
简要总结
The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 16 to 65 year of age
- •Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
- •Willing and able to comply with the study drug regimen
- •Written informed consent before any assessment
排除标准
- •Patient has a history of/or clinical signs/symptoms of hepatic decompensation
- •Patient has a history of HCC or findings suggestive of possible HCC
- •Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
- •History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
- •Patient has received IFN or other immunomodulatory treatment with 12 months before screening
- •Previous treatment history with NRTIs
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: Telbivudine (Drug)
结局指标
主要结局
HBV DNA PCR negativity rate
时间窗: at 52 weeks
次要结局
- HBV DNA PCR negativity rate(at week 24)
- DNA reduction(from baseline to Weeks 12, 24, 36, 52)
- HBeAg loss rate(at week 52)
- HBeAg seroconversion rate(at week 52)
- ALT normalization rate(at weeks 24 and 52)
- Incidence of AE (SAE,etc), Graded lab abnormalities(at week 52)
研究者
研究点 (1)
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