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

Phase 4

Completed

• Conditions: Chronic Liver Disease
• Interventions: Drug: DWJ1464; Drug: Placebo of DWJ1464

• Registration Number: NCT06272630
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-22
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWJ1464	DWJ1464	UCDA 100 mg, TID
Placebo of DWJ1464	Placebo of DWJ1464	Placebo of DWJ1464, TID

Primary Outcome Measures

Name	Time	Method
At 8 weeks, the change of ALT level compared to baseline	8 weeks after randomization

Secondary Outcome Measures

Name	Time	Method
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 8 weeks, the change of liver function comparator Fibrotest 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

Trial Locations

Locations (1)

SoonChunHyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of