Maintaining Antiviral Efficacy After Switching to Generic Entecavir, Baracle® in Patients Taking Baraclude® 1 mg for Antiviral Resistant Chronic Hepatitis B; A Noninferiority Study Assessing Non-detection Rate of Hepatitis B Virus DNA
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Non-detection rate of hepatitis B virus DNA
研究概览
简要总结
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance.
The primary aim is virological response (<20 IU/mL) at 12 months
详细描述
This study is a prospective single-arm open-label trial. The primary endpoint is virological response (<20 IU/mL) at 12 months after switching treatment.
Patients who satisfy the inclusion and exclusion criteria will switch from Baraclude® 1 mg to Baracle®. Assessment of treatment response at 12 months is performed by comparing undetectable HBV DNA rates between baseline and 12 months after switching therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >19 years old CHB patients
- •Confirmed antiviral resistance
- •Taking brand entecavir 1 mg for more than 1 year
- •HBV DNA < 20 IU/mL
- •Compensated liver cirrhosis
- •Willing to participate
排除标准
- •Failure to meet the inclusion criteria
- •Cr>1.5 mg/dL
- •Postive HCV Ab
- •Decompensated cirrhosis
- •Pregnant women
- •Alcoholics
研究组 & 干预措施
Baracle
Chronic hepatitis B patients who swiched to Baracle® 1 mg from Baraclude® 1 mg treatment as mono- or combination therapy after the development of antiviral resistance to nucleos(t)ide analogues
干预措施: Switching to Generic Entecavir (Baracle®) (Drug)
结局指标
主要结局
Non-detection rate of hepatitis B virus DNA
时间窗: 12 months
undetectable HBV DNA (\<20 IU/mL) at 12 months after switching treatment.
次要结局
- Normalization of liver enzyme(12 months)
- Loss of serological markers of hepatitis B e antigen(12 months)
- Signs of newly developing antiviral resistance(12 months)