A Comparative Study of the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir

Bristol-Myers Squibb1 个研究点分布在 1 个国家目标入组 228 人2008年7月

适应症Hepatitis B, Chronic

干预措施Entecavir Adefovir/Entecavir

相关药物Entecavir Adefovir/Entecavir

概览

阶段: 4 期
干预措施: Entecavir
疾病 / 适应症: Hepatitis B, Chronic
发起方: Bristol-Myers Squibb
入组人数: 228
试验地点: 1
主要终点: Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing
状态: 已完成
最后更新: 13年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir

注册库

clinicaltrials.gov

开始日期

2008年7月

结束日期

2011年1月

最后更新

13年前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Bristol-Myers Squibb

责任方

Sponsor

入排标准

入选标准

•Chronic infection with hepatitis B virus (HBV)(detectable hepatitis B surface antibody (HBsAg) at screening and at least 24 weeks prior to screening, or detectable HBsAg for \<24 weeks and negative for immunoglobulin M core antibody)
•Documentation of hepatitis B e antigen (HBeAg) positive or negative status
•Naive to nucleoside/nucleotide analogues, with the exception of adefovir
•Suboptimal response to adefovir treatment
•No lamivudine/telbivudine, entecavir, or adefovir resistance-associated substitutions at screening
•Male or female gender, aged 16 years and older
•Compensated liver function
•Serum alanine aminotransferase level \<10\*upper limit of normal at screening

排除标准

•Women who are pregnant or breastfeeding
•Evidence of decompensated cirrhosis
•Coinfection with HIV, hepatitis C virus, or hepatitis D virus
•Recent history of pancreatitis (within 24 weeks prior to the first dose of study medication)
•Chronic renal insufficiency, defined as a creatinine clearance \<50 mL/min
•Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
•Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
•Serum creatinine level \>1.5 mg/dL; hemoglobin level \<10.0 g/dL; platelet count \<70,000/mm\^3; absolute neutrophil count \<1500 cells/mm\^3; serum alpha fetoprotein level \>100 ng/mL
•Except adefovir, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (eg, lamivudine, entecavir), or any other experimental anti-HBV antiviral, or any China Traditional Medicine
•Therapy with interferon, thymosin alpha, or other immunostimulators within 24 weeks of randomization

研究组 & 干预措施

Entecavir, 0.5 mg QD

干预措施: Entecavir

Adefovir, 10 mg QD/Entecavir, 0.5 mg QD

Control

干预措施: Adefovir/Entecavir

结局指标

主要结局

Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing

时间窗: At Week 12 from Day 1

HBV DNA Level \<50 IU/mL=approximately 300 copies/mL.

次要结局

Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing(At Week 48 from Day 1)
Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion(At Weeks 12 and 48 from Day 1)
Number of Participants With Genotypic Resistance to Entecavir(At Week 48 from Day 1)
Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results(Day 1 through Week 48)
Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT)(At Weeks 12 and 48 from Day 1)
Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing(At Weeks 12 and 48 from Day 1)
Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation(Continually from Day 1 through Week 48, and through 24-week follow-up period)
Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion(At Weeks 12 and 48 from Day 1)