HBV Viral Suppression by Entecavir in Adefovir Partial Responders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- HBV DNA PCR after 12 weeks of entecavir from the time of medication switching: percent of patients with <2log drop in HBV DNA and percent of patients with complete viral suppression during adefovir versus during entecavir.
研究概览
简要总结
We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.
详细描述
Amendment was made, and approved by WIRB in January 2009, to this protocol: We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. The aim of the study is to describe sequential virologic response to adefovir and entecavir.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
Group 1
Persistent viremia after 48 weeks or longer.
干预措施: Entecavir (Drug)
Group 2
<2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir
干预措施: Entecavir (Drug)
Group 3
Patients who responded to adefovir and were switched to entecavir.
干预措施: Entecavir (Drug)
Group 4
Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch.
干预措施: Entecavir (Drug)
结局指标
主要结局
HBV DNA PCR after 12 weeks of entecavir from the time of medication switching: percent of patients with <2log drop in HBV DNA and percent of patients with complete viral suppression during adefovir versus during entecavir.
时间窗: 48 weeks or after
次要结局
- HBV DNA PCR after 24 weeks of entecavir from the time of medication switching.(48 weeks or after)
- BR and CR for longer duration of therapy if available.(48 weeks or after.)
- BR and CR at 24 and 48 weeks of therapy with entecavir.(48 weeks or after.)
- HBV DNA PCR after 48 weeks of entecavir from the time of medication switching.(48 weeks or after)