Conditions: Chronic Hepatitis B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Detailed description:

Arms:
arm 1: Entecavir + Lamivudine placebo (0-96 weeks)

Entecavir (96-240 weeks) arm 2: Lamivudine + Entecavir placebo (0-96 weeks)

Lamivudine (96-240 weeks)

Interventions: intervention 1: Entecavir intervention 2: Lamivudine Placebo intervention 3: Lamivudine intervention 4: Entecavir Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks) intervention 2: Capsules, Oral, 0 mg, once daily (0-96 weeks) intervention 3: Capsules, Oral, 100 mg, once daily (0-96 weeks)

Tablets, Oral, 100 mg, once daily (96-240 weeks) intervention 4: Tablets, Oral, 0 mg, once daily (0-96 weeks)

Protocol document: