At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 44 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 Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB)
In Brief
A Phase 3 clinical trial evaluating Entecavir and Telbivudine for Hepatitis B and Chronic Hepatitis B. Completed, enrolled 44 participants across 8 sites.
Detailed Summary
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic Hepatitis B
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionFeb 2008
TodayJul 2026
First PostedDec 18, 2006
Enrollment StartDec 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.5 years ago
Interventions
Entecavirdrug
Entecavir 0.5 mg once daily for 12 weeks.
Telbivudinedrug
Telbivudine 600 mg once daily for 12 weeks.