At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 166 enrolled
Drug / intervention
GSK548470 300 mg tablet +1 moredrug
Likely dose
GSK548470 300 mg tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Active Controlled, Double-blind, Parallel Group Comparison Study and Subsequent Open-label Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
In Brief
A Phase 3 clinical trial evaluating GSK548470 300 mg tablet and ETV 0.5 mg capsule for Hepatitis B, Chronic. Completed, enrolled 166 participants across 32 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionJan 2013
Study CompletionNov 2014
TodayJul 2026
First PostedNov 28, 2011
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2013
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.6 years ago
Interventions
GSK548470 300 mg tabletdrug
Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate
ETV 0.5 mg capsuledrug
Brown capsules, each capsule containing 0.53 mg of entecavir hydrate