An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- The Proportion of Participants Who Experienced Virologic Breakthrough
研究概览
简要总结
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration [FDA] for the treatment of hepatitis B virus [HBV]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.
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 chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.
- •Previous or current lamivudine treatment
- •HBV DNA > 6 log10 copies/mL
- •Evidence of viral breakthrough
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
- •Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Combination therapy
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
干预措施: telbivudine (Drug)
Combination therapy
Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
干预措施: adefovir dipivoxil (Drug)
Adefovir monotherapy
Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
干预措施: adefovir dipivoxil (Drug)
结局指标
主要结局
The Proportion of Participants Who Experienced Virologic Breakthrough
时间窗: 96 Weeks
Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.
次要结局
- Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration(Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks)
- Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria(12 week, 24 week, 48 week and 60 weeks)
- Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough(Week 96)