At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Entecavir +1 moredrug
Likely dose
Entecavir 1 mgfrom 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 Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure
In Brief
A Phase 3 clinical trial evaluating Entecavir and Tenofovir for Chronic Hepatitis B. Completed, enrolled 144 participants across 28 sites in 7 countries.
Detailed Summary
The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesFrance, Germany, Italy, Netherlands, Poland, Romania, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2010
Enrollment StartMay 2010
Primary CompletionNov 2012
Study CompletionFeb 2014
TodayJul 2026
First PostedFeb 5, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2012
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.4 years ago
Interventions
Entecavirdrug
Tablets, Oral, 1 mg, once daily, 96 weeks
Tenofovirdrug
Tablets, Oral, 300 mg, once daily, 96 weeks