A Phase II Study in Japan of the Safety and Antiviral Activity of Entecavir (BMS-200475) vs Lamivudine in Adults With Chronic Hepatitis B Infection

简要总结

主要结局

次要结局

• Incidence of clinical adverse events and discontinuations due to adverse events in each entecavir group in comparison to lamivudine(Through Week 24 (end of dosing) plus 5 days)
• Incidence of laboratory abnormalities in each entecavir group in comparison to lamivudine(Through Week 24 (end of dosing) plus 5 days)
• HBV DNA as measured by PCR (log10 copies/mL) at Week 22 [to demonstrate non-inferiority of at least one dose of entecavir as compared with lamivudine](Week 22)
• Proportion of subjects in each treatment group who achieve HBV DNA reduced by ≥2 log10 and/or below the limit of quantification (LOQ) (<400 copies/mL) as measured by PCR assay(Week 12, Week 22)
• Proportion of subjects in each treatment group who achieve HBV DNA below the limit of detection (0.7 MEq/mL) of the Quantiplex branched DNA hybridization assay (Quantiplex assay)(Week 22)
• Proportion of subjects in each treatment group who achieve normalization of ALT (ALT <1.25 x UKN)(Week 22)
• Proportion of subjects in each treatment group who achieve loss of HBeAg at Week 22 among HBeAg-positive subjects at baseline(Baseline, Week 22)
• Proportion of subjects in each treatment group who achieve seroconversion at Week 22 among of HBeAg-positive subjects at baseline(Week 22)
• Proportion of HBeAg-positive subjects at baseline who achieve responder status (defined as: HBV DNA <0.7 MEq/mL by the Quantiplex assay; loss of HBeAg and normal serum ALT)(Week 22)
• Proportion of HBeAg-negative subjects at baseline who achieve responder status (defined as HBV DNA <0.7 MEq/mL by the Quantiplex assay and normal serum ALT)(Week 22)
• Incidence of genotypic resistance of HBV isolates in subjects who have a ε 1 log10 increase in HBV DNA as measured by PCR assay after achieving the lowest value while on study drug(Through Week 24)
• Relationship of HBV isolates (genotypes A, B, C etc) at baseline compared to response(Week 22)