At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 228 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 the Week 12 Antiviral Efficacy and Safety of Switching to Entecavir vs. Continuing Adefovir Treatment in Adults With Chronic Hepatitis B and Suboptimal Response to Adefovir
In Brief
A Phase 4 clinical trial evaluating Entecavir and Adefovir/Entecavir for Hepatitis B, Chronic. Completed, enrolled 228 participants across 8 sites.
Detailed Summary
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesChina
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionDec 2009
Study CompletionJan 2011
TodayJul 2026
First PostedJul 21, 2008
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.9 years ago
Interventions
Entecavirdrug
Tablets, Oral, 0.5 mg, once daily (QD), 52 weeks
Adefovir/Entecavirdrug
Tablets, Oral, 10-mg adefovir QD for 12 weeks followed by 0.5-mg entecavir QD for a maximum of 52 weeks