drugset / Trial / NCT00316719

Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

NCT00316719 ↗

Phase 3 Completed 105 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Timeline

Start
2006-01
Primary completion
2008-01
Completion
2008-01

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Adefovir (ADV) vs Lamivudine (LAM); p <0.001; Mean Difference (Net) -0.33 (95% CI -0.94 to 0.28); ANCOVA NCT00316719 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Adefovir dipivoxil Small molecule 10 mg Oral
Comparator Lamivudine Other / unclassified 100 mg Oral