NCT00393484已完成4 期
A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved a Virologic Response at Week 24
研究概览
简要总结
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nucleoside and nucleotide-naive subjects with chronic HBV infection
- •Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
- •Detectable HBsAg
- •HBV DNA ≥ 105 copies/mL by PCR
- •ALT 1.3 to 10 x the ULN
- •HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
排除标准
- 未提供
研究组 & 干预措施
Arm A
Experimental
Entecavir + Lamivudine placebo (0-96 weeks)
Entecavir (96-240 weeks)
干预措施: Entecavir (Drug)
Arm A
Experimental
Entecavir + Lamivudine placebo (0-96 weeks)
Entecavir (96-240 weeks)
干预措施: Lamivudine Placebo (Drug)
Arm B
Active Comparator
Lamivudine + Entecavir placebo (0-96 weeks)
Lamivudine (96-240 weeks)
干预措施: Lamivudine (Drug)
Arm B
Active Comparator
Lamivudine + Entecavir placebo (0-96 weeks)
Lamivudine (96-240 weeks)
干预措施: Entecavir Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Virologic Response at Week 24
时间窗: At Week 24
Virologic response=Hepatitis B virus DNA \<300 copies/mL by polymerase chain reaction assay.
次要结局
- Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96(At Weeks 24, 48, and 96)
- Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24(Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period)
- Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240(At Weeks 48, 96, 144, 192, and 240)
- Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240(At Weeks 24, 48, 96, 144, 192, and 240)
- Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24(Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period)
- Number of Participants With Virologic Rebound at Week 24(At Week 24)
- Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24(At Week 24)
- Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96(At Weeks 24, 48, and 96)
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24(Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period)
- Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24(Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period)
- Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96(Start of dosing (Day 1) until Week 96)
- Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96(At 96 weeks)
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240(Start of dosing (Day 1) until end of treatment (Week 240) + 5 days)
研究者
研究点 (1)
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