The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly. All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Korea University Ansan Hospital
Ansan-si, South Korea
RECRUITINGBundang CHA medical center
Bundang, South Korea
RECRUITINGIncheon St. Mary Hospital
Incheon, South Korea
The proportion of normalization of ALT level (≤1× ULN)(%)
Time frame: At the 4 weeks
The proportion of normalization of ALT level (≤1× ULN)(%)
Time frame: At the 2, 8, 12, 24, 36, 48 weeks
The change of fibrosis marker(ELF score) compared with the baseline
Time frame: At the 48 weeks
The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline
Time frame: At the 12, 24, 48 weeks
The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)
Time frame: At the 24, 48 weeks
The change of HBV DNA level compared with baseline (IU/mL)
Time frame: At the 12, 24, 36, 48 weeks
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Severance Hospital
Seoul, South Korea
RECRUITINGAjou University Medical Center
Suwon, South Korea
RECRUITINGUijeongbu St. Mary Hospital
Uijongbu, South Korea
RECRUITING