A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks. 2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Korea University Guro Hospital
Seoul, South Korea
Difference of HBV DNA level(log10)
Time frame: Change from baseline at 48 weeks
Percentage of subjects HBV DNA < 400 copies/ml
Time frame: at 24 weeks, 48 weeks
Percentage of subjects who had normal ALT levels
Time frame: at 24 week, 48 week
Percentage of subjects who experienced loss of HBeAg
Time frame: at 24 week, 48 week
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