The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
University Hospital
Basel, Switzerland
The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.
Time frame: The primary efficacy endpoint is the rate of viral breakthrough at week 108.
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