Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Summary

This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

Timeline

Start

2003-08

Primary completion

2008-10

Completion

2013-05

Outcome

Met primary endpoint

registry Entecavir (ETV) 1.0 mg vs Adefovir (ADV) 10 mg; p <0.0001; Mean Difference (Final Values) -1.74 (95% CI -2.30 to -1.18) NCT00065507 ↗

Drugs

Indications