Chronic Liver Disease
Conditions
Brief summary
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.
Interventions
DRUGDWJ1464
DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
DRUGPlacebo of DWJ1464
Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Chronic liver disease(presented with abnormal serum ALT levels \>6 months and twice continuously or abnormal area of liver through medical imaging test within 6 months * Abnormal serum ALT levels at screening and baseline
Exclusion criteria
* Subjects who have diseases that liver cirrhosis, liver cancer, renal dysfunction etc. * Subjects who are taking medications or supplements related to chronic liver disease, fatigue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 8 weeks, the change of ALT level compared to baseline | 8 weeks after randomization |
Secondary
| Measure | Time frame |
|---|---|
| At 4, 8 weeks, the change of AST level compared to baseline | 4, 8 weeks after randomization |
| At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline | 4, 8 weeks after randomization |
| At 4 weeks, the change of ALT level compared to baseline | 4 weeks after randomization |
| At 8 weeks, the change of liver function comparator Fibroscan compared to baseline | 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 | 4, 8 weeks after randomization |
| At 8 weeks, the change of liver function comparator Fibrotest compared to baseline | 4, 8 weeks after randomization |
Countries
South Korea
Outcome results
None listed