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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1464 | Experimental | UCDA 100 mg, TID |
|
| Placebo of DWJ1464 | Placebo Comparator | Placebo of DWJ1464, TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1464 | Drug | DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| At 8 weeks, the change of ALT level compared to baseline | 8 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| At 4 weeks, the change of ALT level compared to baseline | 4 weeks after randomization | |
| At 4, 8 weeks, the change of AST level compared to baseline | 4, 8 weeks after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Young Jang, MD, PhD | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SoonChunHyang University Seoul Hospital | Seoul | 04401 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42153228 | Derived | Chang Y, Cho YK, Kim YS, Kim SE, Cheon GJ, Kim JH, Yang H, Kim W, Ahn SB, Yoon EL, Cheong JY, Lee JW, Kim MY, Kim HJ, Lee SH, Cho EY, Choi NR, Lee HW, Kim KM, Choe WH, Yu JM, Kim SY, Jang JY. Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Korean Med Sci. 2026 May 18;41(19):e89. doi: 10.3346/jkms.2026.41.e89. |
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| Placebo of DWJ1464 |
| Drug |
Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week |
|
| At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline |
| 4, 8 weeks after randomization |
| At 8 weeks, the change of liver function comparator Fibrotest compared to baseline | 4, 8 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 |