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

NCT06272630 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2024-12-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Principal Investigators

  • Jae Young Jang, MD, PhD · Soonchunhyang University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-03-29
Completion
2024-03-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06272630 on ClinicalTrials.gov