NCT02482272Unknown4 期
Efficacy and Safety of Continuing Lamivudine Plus Adefovir or Adefovir Versus Switching to Entecavir Plus Adefovir in Patients With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir or Adefovir Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Proportion of patients with HBV DNA<15IU/mL
研究概览
简要总结
The purpose of this study is to compare efficacy and safety of continuing Lamivudine plus Adefovir or Adefovir versus switching to Entecavir plus Adefovir in patients with LAM-resistant chronic hepatitis B who have suboptimal response to Lamivudine plus Adefovir or 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B
- •Age ≥ 20 year old
- •Currently taking Lamivudine and Adefovir combination therapy or Adefovir monotherapy for chronic HBV infection for 24 weeks
- •Proven Lamivudine resistant mutation
- •HBV DNA levels at screening ≥ 15 IU/mL
- •Females must be post-menopausal, unable to conceive, or test negative for pregnancy via urine test
- •Patient is able to give written informed consent prior to study start and to comply with the study requirements
排除标准
- •A history or current of decompensated cirrhosis or hepatocellular carcinoma
- •Currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy
- •Co-infected with HCV or HIV
- •A history of organ transplantation
- •Pregnant or breast-feeding
- •Current clinically relevant of abuse of alcohol or drugs.
- •Significant immunocompromised, gastrointestinal, renal(serum creatinine ≥ 1.5 mg/dL), hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy
- •malignancy in previous 5 years
研究组 & 干预措施
Lamivudine plus Adefovir or Adefovir
Active Comparator
Lamivudine+Adefovir or Adefovir for 48 weeks
干预措施: Lamivudine (Drug)
Lamivudine plus Adefovir or Adefovir
Active Comparator
Lamivudine+Adefovir or Adefovir for 48 weeks
干预措施: Adefovir (Drug)
Entecavir plus Adefovir
Experimental
Entecavir+Adefovir for 48 weeks
干预措施: Adefovir (Drug)
Entecavir plus Adefovir
Experimental
Entecavir+Adefovir for 48 weeks
干预措施: Entecavir (Drug)
结局指标
主要结局
Proportion of patients with HBV DNA<15IU/mL
时间窗: week 48
次要结局
- Proportion of patients with ALT normalization(Day1, week12, week 24, week 36, week 48)
- Assessment the safety in all patients (composite measure of AE, labs, phys. exam, vital signs)(week 48)
- Proportion of patients with HBeAg loss and/or seroconversion(Day1, week12, week 24, week 36, week 48)
- The change of HBsAg from the baseline(week 48)
- Proportion of patients with HBsAg loss and/or seroconversion(week 24, week 48)
- Proportion of patients with HBV DNA<15IU/mL(Day1, week12, week 24, week 36, week 48)
- The change of HBV DNA from the baseline(week 48)
- Proportion of patients who experienced virologic breakthrough(week 48)
研究者
研究点 (1)
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