NCT00640588已完成3 期
Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine
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
- 30
- 试验地点
- 1
- 主要终点
- HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
研究概览
简要总结
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age.
- •Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.
排除标准
- •Co-infection with HCV, HDV, or HIV.
- •Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
- •History of hepatic decompensation
- •History of malignancy
- •Patient has one or more additional known primary or secondary causes of liver disease
研究组 & 干预措施
1
Experimental
Telbivudine
干预措施: Telbivudine (Drug)
2
Active Comparator
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
干预措施: oral adefovir (Drug)
结局指标
主要结局
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
时间窗: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks
次要结局
- Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline(at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks)
研究者
研究点 (1)
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