NCT00412529已完成3 期
A Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB)
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
- 44
- 试验地点
- 8
- 主要终点
- Change in Mean Hepatitis B Virus (HBV) DNA Levels
研究概览
简要总结
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.
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
- •Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
- •Able to comply with study regimen and provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Unwilling to use double barrier method of contraception
- •Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- •Received Hepatitis B therapy in the past
- •Use of immunomodulatory therapy in past 12 months
- •History of or symptoms of hepatic decompensation or pancreatitis
- •Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
- •Concurrent medication likely to preclude compliance with schedule of evaluations
- •Use of other investigational drugs within 30 days of enrollment
- •Abnormal laboratory values during screening
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Telbivudine
Experimental
干预措施: Telbivudine (Drug)
Entecavir
Active Comparator
干预措施: Entecavir (Drug)
结局指标
主要结局
Change in Mean Hepatitis B Virus (HBV) DNA Levels
时间窗: Baseline (day 1) to Week 12 (day 85)
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.
次要结局
- Change in Alanine Aminotransferase (ALT) Levels(From Baseline to Week 12)
- Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance(Baseline to 12 weeks)
- Change in Mean HBV DNA Level(Baseline (day 1) to Weeks 2, 4, 8)
- The Area Under the Curve (AUC) of HBV DNA Change.(From Baseline to Week 12)
- Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss(Baseline to 12 weeks)
- Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production(Baseline to 12 weeks)
- Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative(At Week 12)
研究者
研究点 (8)
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