At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,053 enrolled
Drug / intervention
Entecavir +1 moredrug
Likely dose
Entecavir 1.0 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 Preliminary Assessment of Safety and Antiviral Activity of Open-label Entecavir in Subjects With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
In Brief
A Phase 2 clinical trial evaluating Entecavir and Lamivudine for Hepatitis B Virus and HBV. Completed, enrolled 1,053 participants.
Detailed Summary
The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Virus, HBV
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2001
Primary CompletionDec 2009
Study CompletionApr 2011
First PostedSep 2011
TodayJul 2026
First PostedSep 22, 2011
Enrollment StartJan 1, 2001
Primary CompletionDec 1, 2009
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 14.8 years ago
Interventions
Entecavirdrug
Tablets, Oral, 1.0 mg, once daily
Lamivudinedrug
Oral, 100 mg, daily