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 Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06272630
• Other study ID #: DW_DWJ1464401
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 258
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Drug:
• DWJ1464
DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
• Placebo of DWJ1464
Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week

Locations

Country	Name	City	State
Korea, Republic of	SoonChunHyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At 8 weeks, the change of ALT level compared to baseline		8 weeks after randomization
Secondary	At 4 weeks, the change of ALT level compared to baseline		4 weeks after randomization
Secondary	At 4, 8 weeks, the change of AST level compared to baseline		4, 8 weeks after randomization
Secondary	At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline		4, 8 weeks after randomization
Secondary	At 8 weeks, the change of liver function comparator Fibrotest compared to baseline		4, 8 weeks after randomization
Secondary	At 8 weeks, the change of liver function comparator Fibroscan compared to baseline		4, 8 weeks after randomization
Secondary	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