Conditions: Hepatitis B, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 669
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Detailed description:

Arms:
arm 1: TDF=tenofovir arm 2: ETV=entecavir; TDF=tenofovir

Interventions: intervention 1: Entecavir intervention 2: Entecavir + Tenofovir
Intervention descriptions: intervention 1: Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks intervention 2: Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks

Protocol document: