CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Adefovir +2 moredrug
Likely dose
Adefovir 10 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/NCT01023217
NCT01023217Phase 4Completed
CompareCT.gov

Continuation of Lamivudine Plus Adefovir Versus Switching to Entecavir Plus Adefovir in Adults With Chronic Hepatitis B Who Have Resistant Mutants to Lamivudine and Show Suboptimal Response to Combination of Lamivudine Plus Adefovir

Asan Medical Center·interventional·Posted Dec 2, 2009·Updated Feb 10, 2014

In Brief

A Phase 4 clinical trial evaluating Adefovir, Entecavir, and 1 other intervention for Hepatitis B, Chronic. Completed, enrolled 90 participants across 1 site.

Detailed Summary

The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV) and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who show suboptimal response to the combination of LAM and ADV. In this randomized, open labeled trial,the investigators will compare the efficacy of continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and LAM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2009
Enrollment StartNov 1, 2009
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.6 years ago

Interventions

Adefovirdrug

Adefovir dipivoxil (Hepsera) 10 mg/day orally for 104 weeks

Entecavirdrug

Entecavir 1 mg/day orally

Lamivudinedrug

Lamivudine (Zeffix) 100 mg/day orally