Chronic Hepatitis B Clinical Trial
Official title:
Maintaining Antiviral Efficacy After Switching to Generic Entecavir, Baracle® in Patients Taking Baraclude® 1 mg for Antiviral Resistant Chronic Hepatitis B; A Noninferiority Study Assessing Non-detection Rate of Hepatitis B Virus DNA
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with
previous antiviral resistance. This study evaluates the efficacy and safety of switching to
generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand
name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other
nucleos(t)ide analogues after the development of antiviral resistance.
The primary aim is virological response (<20 IU/mL) at 12 months
This study is a prospective single-arm open-label trial. The primary endpoint is virological
response (<20 IU/mL) at 12 months after switching treatment.
Patients who satisfy the inclusion and exclusion criteria will switch from Baraclude® 1 mg to
Baracle®. Assessment of treatment response at 12 months is performed by comparing
undetectable HBV DNA rates between baseline and 12 months after switching therapy.
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