Hepatitis B, Chronic Clinical Trial
Official title:
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
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.
In this randomized, open label, two-arm, single center phase IV trial, the investigators
will assess and compare the efficacy and safety of continuation of ADV plus LAM versus
switching to ADV plus ETV up to 52-weeks in Korean adults with chronic hepatitis B who have
resistant mutants to LAM and show suboptimal response to combination of ADV plus LAM.
All study subjects who complete the initial treatments of 52-weeks will be thereafter
treated with the combination of ADV plus ETV for 52 more weeks.
Study period: Nov 2009 - October 2012 Patient enrollment period: November 2009 - December
2010
Study protocol
1. Group A (ADV+LAM group): Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks,
and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
2. Group B (ADV+ETV group): Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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