At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 629 enrolled
Drug / intervention
Entecavir +3 moredrug
Likely dose
Entecavir 1mgfrom 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 Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study
In Brief
A Phase 3 clinical trial evaluating Entecavir, Tenofovir, and 2 other interventions for Hepatitis B, Chronic. Completed, enrolled 629 participants across 67 sites in 18 countries.
Detailed Summary
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesAustralia, Brazil, Canada, Greece, Hong Kong, India, Indonesia, Italy, Malaysia, Philippines, Poland, Russia, Singapore, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2006
Enrollment StartMar 2008
Primary CompletionJan 2011
Study CompletionJul 2012
TodayJul 2026
First PostedDec 12, 2006
Enrollment StartMar 1, 2008
Primary CompletionJan 1, 2011
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.6 years ago
Interventions
Entecavirdrug
Tablets, Oral, 1mg, once daily, 100 weeks
Tenofovirdrug
Tablets, Oral, 300 mg, once daily
Adefovirdrug
Tablets, Oral, 10mg, once daily, 100 weeks
Lamivudinedrug
Tablets, Oral, 100mg, once daily, 100 weeks