CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 122 enrolled
Drug / intervention
Entecavir +3 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.

Search/NCT00393484
NCT00393484Phase 4Completed
CompareCT.gov

A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea

Bristol-Myers Squibb·interventional·Posted Oct 27, 2006·Updated Nov 26, 2014

In Brief

A Phase 4 clinical trial evaluating Entecavir, Lamivudine Placebo, and 2 other interventions for Chronic Hepatitis B. Completed, enrolled 122 participants across 15 sites.

Detailed Summary

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2006
Enrollment StartFeb 1, 2007
Primary CompletionJan 1, 2009
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.7 years ago

Interventions

Entecavirdrug

Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)

Lamivudine Placebodrug

Capsules, Oral, 0 mg, once daily (0-96 weeks)

Lamivudinedrug

Capsules, Oral, 100 mg, once daily (0-96 weeks) Tablets, Oral, 100 mg, once daily (96-240 weeks)

Entecavir Placebodrug

Tablets, Oral, 0 mg, once daily (0-96 weeks)