CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
ADEFOVIR, LAMIVUDINEdrug
Likely dose
ADEFOVIR, LAMIVUDINE 10mgfrom 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/NCT01546116
NCT01546116Phase 4Completed
CompareCT.gov

Efficacy of Adefovir and Lamivudine Combination Therapy in Patients With Entecavir Resistance

Korea University·interventional·Posted Mar 7, 2012·Updated Feb 17, 2014

In Brief

A Phase 4 clinical trial evaluating ADEFOVIR, LAMIVUDINE for Chronic Hepatitis B. Completed, enrolled 20 participants across 9 sites.

Detailed Summary

* Entecavir has been one of the option for treatment of lamivudine resistant chronic hepatitis B (CHB). * In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance. * It is thought that adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B virus (HBV) DNA to be undetectable in patients with entecavir resistance. * This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.

Study Details

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

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2012
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.3 years ago

Interventions

ADEFOVIR, LAMIVUDINEdrug

Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week