At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 669 enrolled
Drug / intervention
Entecavir +1 moredrug
Likely dose
Entecavir 0.5 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 Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study
In Brief
A Phase 3 clinical trial evaluating Entecavir and Entecavir + Tenofovir for Hepatitis B, Chronic. Completed, enrolled 669 participants across 68 sites in 13 countries.
Detailed Summary
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesArgentina, Australia, Brazil, Canada, France, India, Italy, Mexico, Poland, Russia, South Africa, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartApr 2007
Primary CompletionOct 2010
TodayJul 2026
First PostedDec 12, 2006
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.6 years ago
Interventions
Entecavirdrug
Tablets, Oral, ETV = 0.5 mg, once daily, 100 weeks
Entecavir + Tenofovirdrug
Tablets, Oral, ETV = 0.5 mg + TFV = 300 mg, once daily, 100 weeks