A study to evaluate the efficacy and safety of clevudine and peg-interferon in sequence compared with clevudine alone in the patients with HBeAg(+) chronic Hepatitis B or clevudine and peg-interferon sequential treatment in patients with chronic Hepatitis B who have HBeAg(+)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
30mg,QD
30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
Uijeongbu St.Mary's Hospital
Uijeongbu-si, South Korea
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Time frame: At week 48
antiviral activity;Proportion of patients with HBV DNA below LOD(HBV DAN levels < 300 copies/mL) by real time PCR
Time frame: At week 72
antiviral activity: The change of HBV DNA from the baseline
Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
ALT normalization rate
Time frame: Screening, Day1(predose), at week 12, 24, 36, 48, 60, 72
Proportion sustained complete response of patients with complete response
Time frame: At week 72
Immunological endpoints
Time frame: Day1(predose), at week 24, 48, 72
Proportion of patients with HBeAg loss/ HBeAg seroconversion
Time frame: At week 48
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