A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HBV DNA titer < 300 copies/mL
研究概览
简要总结
The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.
详细描述
Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.
In detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive and anti-HBs negative more than 6 months
- •YMDD mutation (+)during lamivudine therapy
- •Serum ALT more than two times upper normal value
排除标准
- •HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
- •The sign of decompensated liver disease
- •Pregnant or lactating woman
- •The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
- •Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
- •Serum creatinine more than 1.5 times upper normal limit value
- •The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
研究组 & 干预措施
Lamivudine plus adefovir
干预措施: adefovir (Drug)
Lamivudine plus adefovir
干预措施: lamivudine (Drug)
Clevudine plus adefovir
干预措施: adefovir (Drug)
Clevudine plus adefovir
干预措施: clevudine (Drug)
结局指标
主要结局
HBV DNA titer < 300 copies/mL
时间窗: 48 week
次要结局
- Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance(48 week)