Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Percentage number of patients with virus reactivation
研究概览
简要总结
This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA
详细描述
Recently, in Korea, long-term medication of antiviral agents and their resulting resistance expression have been the most serious cause of failure to treat chronic hepatitis B. Exp.
In particular, the annual resistance rate to lamivudine currently widely being used in Korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years.
The guidelines by the American Association for the Study of Liver Disease (AASLD) and the European Association for the Study of the Liver (EASL) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant HBV .
In Korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions.
Tenofovir that has been developed most recently and will be placed on sale sooner or later in Korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir.
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
- •Male and female patients aged 18 or older
- •The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.
排除标准
- •Patients with decompensated liver disease
- •Patients with HCV, HDV or HIV
- •Patients with HCC
- •Serum ALT > 2x ULN level
- •Serum creatinine > 2.0mg/dL
- •Pregnant or lactating women
- •Women who have a plan for pregnancy within the three coming years
- •Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection
- •Those who have no capabilities to understand and sign an informed consent
研究组 & 干预措施
Lamivudine plus adefovir
Continue lamivudine/adefovir add on treatment (standard treatment)
干预措施: Lamivudine plus adefovir (Drug)
Tenofovir
Switch from lamivudine/adefovir add on treatment to tenofovir monotherapy
干预措施: Tenofovir (Drug)
结局指标
主要结局
Percentage number of patients with virus reactivation
时间窗: Week 96 while on treatment
Percentage number of patients with virus reactivation (HBV DNA \> 40 IU/mL on two consecutive samples taken 1 month apart, or persistent HBV DNA levels of 20-40 IU/mL on three consecutive 1 month interval) at Week 96 while on treatment.
次要结局
- Biochemical response(Week 96 while on treatment)
- Serologic response(Week 96 while on treatment)
- Virologic response(Week 96 while on treatment)
- Antiviral resistance(Week 96 while on treatment)
- Safety assessment(Week 96 while on treatment)
研究者
Jang Byoung Kuk
Keimyung University Dongsan Medical Center
Keimyung University Dongsan Medical Center