This study aims to assess the effect of DWJ1464 on improvement of liver function in patients with Chronic liver disease. Patients with Chronic liver disease aged 19 years or over will participate in the study. The study design is a multi-center double-blinded randomized placebo-controlled trial. The patients were diagnosed with Chronic liver disease based on our criteria and were randomized to either the placebo or DWJ1464 administration group. Primary endpoint was the change of ALT level after 8 weeks compared to the baseline. Secondary endpoints included the change of ALT level after 4 weeks, the change rate of ALT level after 8 weeks and improvement of fatigue, compared to the baseline. the adverse effect of DWJ1464 were also recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
263
DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
SoonChunHyang University Seoul Hospital
Seoul, South Korea
At 8 weeks, the change of ALT level compared to baseline
Time frame: 8 weeks after randomization
At 4 weeks, the change of ALT level compared to baseline
Time frame: 4 weeks after randomization
At 4, 8 weeks, the change of AST level compared to baseline
Time frame: 4, 8 weeks after randomization
At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline
Time frame: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibrotest compared to baseline
Time frame: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibroscan compared to baseline
Time frame: 4, 8 weeks after randomization
At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline
Time frame: 4, 8 weeks after randomization
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