NCT03489239进行中（未招募）3 期
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Results of viral Hepatitis B DNA to be <20 IU/mL
研究概览
简要总结
A research study to observe the safety, efficacy and tolerability of switching from Entecavir (ETV) to Tenofovir Alafenamide TAF in patients with chronic hepatitis B
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subjects, adult male and female ≥18 years of age with chronic hepatitis B with or without compensated cirrhosis
- •Maintained on Entecavir for a minimum of 48 weeks
- •Viral suppression (HBV DNA <20 IU/mL) for a minimum of 12 weeks prior to entry are eligible for this study.
- •Estimated creatinine clearance ≥ 50 ml/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the baseline evaluation.
排除标准
- •Subjects with known poor or non-compliance
- •Subjects with co-infection with HCV or HIV subjects with decompensated cirrhosis and HCC will be excluded to participate in the study.
- •Pregnant women and those who wish to become pregnant during the course of the study.
研究组 & 干预措施
Single Arm
Experimental
SingleArm: TAF 25 mg
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
Results of viral Hepatitis B DNA to be <20 IU/mL
时间窗: 48 weeks
The proportion of subjects with plasma HBV DNA levels below 20 IU/mL at week 48.
次要结局
- Improved Bone Mass Density at study completion(96 weeks)
- Complete viral suppression at study completion(96 Weeks)
- Positive eGFR changes at study completion compared to Baseline visit(96 weeks)
研究者
研究点 (1)
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