NCT00410072已完成3 期
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study
Bristol-Myers Squibb17 个研究点 分布在 2 个国家目标入组 669 人开始时间: 2007年4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
- 669
- 试验地点
- 17
- 主要终点
- Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
研究概览
简要总结
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
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
- None
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
- •Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
- •Nucleoside- and nucleotide-naive
- •Males or females ≥16 years of age (or minimum age of consent in a given country)
- •Compensated liver function
- •HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
- •HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
- •Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN
排除标准
- •Evidence of decompensated cirrhosis
- •Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- •Laboratory values out of protocol-specified range
研究组 & 干预措施
TDF 0.5 mg
Experimental
TDF=tenofovir
干预措施: Entecavir (Drug)
ETV 0.5 mg +TDF 300 mg
Experimental
ETV=entecavir; TDF=tenofovir
干预措施: Entecavir + Tenofovir (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
时间窗: At Week 96
HBV DNA levels \<50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints.
次要结局
- Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status(At Weeks 48 and 96)
- Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96(At Weeks 48 and 96)
- Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96(At Weeks 48 and 96)
- Mean Log 10 HBV DNA at Weeks 48 and 96(Baseline, Weeks 48 and 96)
- Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96(At Weeks 48 and 96)
- Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96(At Weeks 48 and 96)
- Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96(At Weeks 48 and 96)
- Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96(At Weeks 48 and 96)
- Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96(At Weeks 48 and 96)
- Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96(At Weeks 48 and 96)
- Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities(From enrollment through Week 100 + 24-week follow-up)
- Number of Participants With HBV Resistance Through Week 48(Week 48)
- Number of Participants With HBV Resistance at Week 96(Week 96)
- Number of Participants With Virologic Breakthrough at Week 48(Week 48)
- Number of Participants With Virologic Breakthrough at Week 96(Week 96)
研究者
研究点 (17)
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