NCT06272630

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	DWJ1464	DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
DRUG	Placebo of DWJ1464	Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2024-02-22
• Last updated: 2024-12-30

Locations

1 site across 1 country: South Korea