Conditions: Hepatitis B
Keywords: tenofovir disoproxil fumarate chronic hepatitis B adefovir dipivoxil
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 512
Healthy volunteers: no

Brief summary:
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen \[HBeAg\] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.

Detailed description:
This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative subjects) will be randomised (1:1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms. The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \<400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study. The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV on safety and efficacy endpoints; dosing will be double-blind. This period will be followed by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240). Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12 weeks followed by every 12 weeks for a total of up to 5 years.

Arms:
arm 1: Tenofovir disoproxil fumarate (TDF) tablets arm 2: Adefovir dipivoxil (ADV) tablets

Interventions: intervention 1: Tenofovir disoproxil fumarate (TDF) tablets intervention 2: Adefovir dipivoxil (ADV) tablets
Intervention descriptions: intervention 1: white, almond-shaped, film-coated tablets containing 300mg of TDF intervention 2: white to off-white, round, biconvex tablets containing 10mg of ADV

Protocol document: