NCT01037062已完成2 期
An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
研究概览
简要总结
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
研究设计
- 研究类型
- Interventional
- 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
- •Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
- •ALT ≤ 10 x upper limit of normal;
- •Subjects must have well-compensated liver disease according to ALL of the following criteria;
- •Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
- •Serum albumin ≥ 3 g/dL (≥ 30 g/L)
- •Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)
排除标准
- •Sex and Reproductive Status Exceptions
- •Target Disease Exceptions
- •Medical History and Concurrent Diseases
研究组 & 干预措施
Entecavir
Experimental
干预措施: Entecavir (Drug)
结局指标
主要结局
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
时间窗: 24 weeks
次要结局
- Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing)
- Incidence of laboratory abnormalities of of entecavir for each cohort(Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing)
- Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum(Day 1, Week 12, Week 24 and every subsequent 24 week during dosing)
- Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb)(Day 1, Week 12, Week 24 and every subsequent 24 week during dosing)
- Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48(Day 1, Week 48)
- Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ)(Day 1, Week 12, 24, and subsequent 24 week during dosing)
- Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion(Week 8, 16, 24 post dosing)
- Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg(Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing)
- Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug(24 Week post dosing)
- Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study](Week 48, 96)
- NChanges in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis(Week 48 & Week 96)
- Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment(Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days)
研究者
研究点 (1)
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