A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
2014年11月6日 更新者：Bristol-Myers Squibb
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
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.
研究概览
研究类型
介入性
注册 (实际的)
122
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bucheon、大韩民国、420-717
- Local Institution
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Busan、大韩民国、602-739
- Local Institution
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Chuncheon、大韩民国、200-704
- Local Institution
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Daegu、大韩民国、700-721
- Local Institution
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Daegu、大韩民国、705-030
- Local Institution
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Daejeon、大韩民国、301-721
- Local Institution
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Guri、大韩民国、471-020
- Local Institution
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Jeonju、大韩民国、561-180
- Local Institution
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Seoul、大韩民国、135-710
- Local Institution
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Seoul、大韩民国、136-705
- Local Institution
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Seoul、大韩民国、130-702
- Local Institution
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Seoul、大韩民国、135-270
- Local Institution
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Seoul、大韩民国、138-040
- Local Institution
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Seoul、大韩民国、150-950
- Local Institution
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Seoul、大韩民国、152-050
- Local Institution
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm A
Entecavir + Lamivudine placebo (0-96 weeks) Entecavir (96-240 weeks) |
Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
其他名称：
Capsules, Oral, 0 mg, once daily (0-96 weeks)
|
|
有源比较器：Arm B
Lamivudine + Entecavir placebo (0-96 weeks) Lamivudine (96-240 weeks) |
Capsules, Oral, 100 mg, once daily (0-96 weeks) Tablets, Oral, 100 mg, once daily (96-240 weeks)
Tablets, Oral, 0 mg, once daily (0-96 weeks)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Who Achieved a Virologic Response at Week 24
大体时间：At Week 24
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Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.
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At Week 24
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：At Weeks 24, 48, and 96
|
The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay.
Treatment comparisons will be assessed using the same method as the primary endpoint.
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At Weeks 24, 48, and 96
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Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240
大体时间：At Weeks 24, 48, 96, 144, 192, and 240
|
Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24.
The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.
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At Weeks 24, 48, 96, 144, 192, and 240
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Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24
大体时间：At Week 24
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Mean ALT values from baseline by laboratory test. .
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At Week 24
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Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96
大体时间：At Weeks 24, 48, and 96
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Normalization of serum ALT= ≤*institutional upper limit of normal.
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At Weeks 24, 48, and 96
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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
大体时间：Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Most common AEs=AEs affecting ≥3 participants.
Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
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Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
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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
大体时间：Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
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ALT flares=ALT>2*Baseline and 10*upper limit of normal.
Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
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Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
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Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24
大体时间：Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period
|
ULN=upper limit of normal; ALT=alanine transaminase.
WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
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Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period
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Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24
大体时间：Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
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Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.
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Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
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Number of Participants With Virologic Rebound at Week 24
大体时间：At Week 24
|
Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).
|
At Week 24
|
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Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240
大体时间：At Weeks 48, 96, 144, 192, and 240
|
Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay
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At Weeks 48, 96, 144, 192, and 240
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Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96
大体时间：At 96 weeks
|
Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).
|
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
大体时间：Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
|
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
|
Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
|
|
Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96
大体时间：Start of dosing (Day 1) until Week 96
|
ULN=upper limit of normal; ALT=alanine transaminase.
WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
|
Start of dosing (Day 1) until Week 96
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年2月1日
初级完成 (实际的)
2009年1月1日
研究完成 (实际的)
2013年9月1日
研究注册日期
首次提交
2006年10月26日
首先提交符合 QC 标准的
2006年10月26日
首次发布 (估计)
2006年10月27日
研究记录更新
最后更新发布 (估计)
2014年11月26日
上次提交的符合 QC 标准的更新
2014年11月6日
最后验证
2014年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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