NCT03471624已完成4 期
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 12
- 主要终点
- Number of Participants With HBV DNA <20 IU Per mL
研究概览
简要总结
Primary Objective:
To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment
详细描述
Secondary Objective(s):
- Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment
- To describe trends in serum creatinine and calculated creatinine clearance as available by local labs.
- To describe trends in bone mass from baseline to 24 months after switch.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenofovir Alafenamide for 24 months
Experimental
Participants on any antiviral treatment for chronic HBV who plan to be switched by their physician to be treated with TAF 25 mg for 24 months.
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
Number of Participants With HBV DNA <20 IU Per mL
时间窗: Baseline, 6, 12, 18, 24 months
To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment.
次要结局
- Number of Participants With Normal Alanine Aminotransferase (ALT).(Baseline, 6, 12, 18, 24 months)
- The Mean Bone Mass Density (T-score) Change(Baseline, month 24)
- Calculated eGFR(Baseline, 6, 12, 18, 24 months)
研究者
Mindie H. Nguyen
Profesor of Medicine
Stanford University
研究点 (12)
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