NCT00605384终止3 期
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Versus Adefovir Added to Continuing Lamivudine in Adults With Lamivudine- Resistant Chronic Hepatitis B Virus Infection
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 4 人开始时间: 2008年8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
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48
研究概览
简要总结
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection
- •History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit
- •Compensated liver function
- •HBV DNA ≥ 172,000 IU/mL
- •Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative
排除标准
- •Evidence of decompensated cirrhosis
- •Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
- •Recent history of pancreatitis
- •Serum alpha fetoprotein > 100 ng/mL
- •Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B
研究组 & 干预措施
1
Experimental
干预措施: Entecavir + Tenofovir (Drug)
2
Experimental
干预措施: Adefovir + continuing Lamivudine (Drug)
结局指标
主要结局
Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48
时间窗: Week 48
using the Roche COBAS® TaqMan HBV Test for use with the High Pure System (HPS) assay, by Polymerase Chain Reaction (PCR); HBV DNA \< 50 IU/mL = approximately 300 copies/mL
次要结局
- Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96(Week 96)
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities(Day 1 through end of treatment (Week 100 +/- 5 days))
- Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96(Week 48, Week 96)
- HBV DNA Values at Weeks 48 and 96(Weeks 48, Week 96)
- Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96(Week 48, Week 96)
- Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96(Week 48, Week 96)
- Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96(Baseline, Week 48, Week 96)
- Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96(Baseline, Week 48, Week 96)
- Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96(Week 48, Week 96)
- Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96(Week 48, Week 96)
- Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96(Week 48, Week 96)
研究者
研究点 (4)
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