Conditions: Hepatitis B, Chronic
Keywords: Tenofovir Disoproxil Fumarate Chronic Hepatitis B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 166
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.

Detailed description:
This study is a multicenter, randomized, active comparator-controlled, double-blind, parallel-group comparison study in Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue and its subsequent open-label study. Efficacy and safety will be compared between once-daily dosing of GSK548470 300 mg and once-daily dosing of ETV 0.5 mg, and subsequently the efficacy and safety of GSK548470 administered long term will be investigated. A total of 165 subjects will be assigned to the GSK548470 group or the ETV group at a ratio of 2:1. The subjects will be assigned by stratified randomization in terms of HBe antigen and serum HBV-DNA level. The primary purpose is to verify the non-inferiority of GSK548470 to ETV using as an index the change amount of HBV-DNA level at Week 24 from the baseline level. The secondary purpose is to investigate the efficacy and safety of GSK548470 300 mg administered once daily for a long term.

Arms:
arm 1: GSK548470 300 mg tablet and ETV placebo capsule are administered once daily arm 2: ETV 0.5 mg capsule and GSK548470 placebo tablet are administered once daily

Interventions: intervention 1: GSK548470 300 mg tablet intervention 2: ETV 0.5 mg capsule
Intervention descriptions: intervention 1: Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate intervention 2: Brown capsules, each capsule containing 0.53 mg of entecavir hydrate

Protocol document: