Conditions: Hepatitis B
Keywords: hepatic decompensation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 195
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Entecavir (ETV) intervention 2: Adefovir (ADV)
Intervention descriptions: intervention 1: Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized intervention 2: Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Protocol document: