Conditions: Chronic Hepatitis B
Keywords: tenofovir adefovir hepatitis B virus HBeAg Negative
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 382
Healthy volunteers: no

Brief summary:
This primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.

Detailed description:

Arms:
arm 1: TDF plus ADV placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC tablet) to their treatment regimen in the open-label period. arm 2: ADV plus TDF placebo (double-blind period), followed by TDF (open-label period). Participants may add FTC (as part of FTC/TDF FDC tablet) to their treatment regimen in the open-label period.

Interventions: intervention 1: TDF intervention 2: ADV intervention 3: TDF placebo intervention 4: ADV placebo intervention 5: FTC/TDF
Intervention descriptions: intervention 1: 300 mg tablet administered orally once daily intervention 2: 10 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily intervention 5: 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily

Protocol document: