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Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease

Chronic Liver Disease Clinical Trial

Official title:
A Multicenter, Randomized, Placebo Controlled, Double-blinded, Phase 4 Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06272630
Study type Interventional
Source Daewoong Pharmaceutical Co. LTD.
Contact
Status Enrolling by invitation
Phase Phase 4
Start date February 6, 2023
Completion date August 31, 2024
View Details
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