NCT00975091已完成3 期
A Study of the Safety and Antiviral Activity of Open-Label Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Dosing in a Previous Phase II/III Study in China
Bristol-Myers Squibb0 个研究点目标入组 600 人开始时间: 2004年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
研究概览
简要总结
The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
- •ALT ≤ 15 x upper limit of normal
- •Compensated liver disease
排除标准
- •Coinfection with HIV, HCV, or HDV
研究组 & 干预措施
Entecavir 0.5
Active Comparator
干预措施: Entecavir (Drug)
Entecavir 1.0
Active Comparator
干预措施: Entecavir (Drug)
结局指标
主要结局
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events
时间窗: Through 3 years of dosing and up to 48 weeks of off treatment follow up
次要结局
- The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort(Through 3 years of dosing)
研究者
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