Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naive Adults With Chronic Hepatitis B Infection

简要总结

主要结局

次要结局

• Change From Baseline in HBV DNA by PCR Assay at Week 48(Baseline, Week 48)
• Viral Load Undetectable (HBV DNA <300 Copies/mL)(Week 48)
• Alanine Aminotransferase (ALT) Normalization(Week 48)
• HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections(Week 12)
• HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate(Week 12)
• HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus(Week 12)
• HBV DNA Viral Kinetics - Spline Model(Week 12)
• Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths(cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset)
• Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs(Week 48)