NCT00710216撤回4 期
Randomized, Open-Label, Phase IV Trial in Nucleus(t)id-Naive Patients With Chronic Hepatitis B to Examine the Effect of Telbivudine Compared to Lamivudine on the Early Dynamics and Kinetics of Viral Suppression (Early-Viral-Dynamics Study)
University of Ulm1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
研究概览
简要总结
This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented compensated HBeAg-positive or negative chronic hepatitis B
- •Increased viral load with a concentration of serum HBV-DNA of at least 10^4 copies/ml
- •Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
- •Negative urine pregnancy test with fertile women
- •Willingness to use a recognized method of contraception
- •Able to comply with study regimen and provide written informed consent
排除标准
- •Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
- •Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
- •Pregnant or breastfeeding women or women
- •Simultaneous participation in other clinical trials or in the past three months
- •Co-infected with HCV, HDV, HIV
- •Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
- •Evidence of hepatocellular carcinoma (alpha-fetoprotein levels> 100 ng/ml)
- •Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
- •Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
- •Lack of willingness or inability to consent in writing
- •Concurrent condition likely to preclude compliance with schedule of evaluations
研究组 & 干预措施
A
Active Comparator
干预措施: Lamivudine (Drug)
B
Experimental
干预措施: Telbivudine (Drug)
结局指标
主要结局
Decrease in viral load after 2 weeks of therapy measured in serum HBV-DNA concentration (Copies/ml or IU/ml).
时间窗: 2 weeks
次要结局
- Course of the viral load (serum HBV-DNA) during the first 12 weeks of therapy(12 weeks)
- Influence of HBeAg status to the decrease in viral load(12 weeks)
- Influence of HBV genotype to the decrease in viral load(12 weeks)
- Change in ALT and AST levels from Baseline to Week 12(12 weeks)
- Development of viral resistance and treatment failure during the study and subsequent course of observation(6 month)
- Safety assessed by adverse events and laboratory values(6 month)
研究者
研究点 (1)
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