MedDataX Logo

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

NCT ID: NCT06272630

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2024-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DWJ1464

UCDA 100 mg, TID

Group Type EXPERIMENTAL

DWJ1464

Intervention Type DRUG

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

Placebo of DWJ1464

Placebo of DWJ1464, TID

Group Type PLACEBO_COMPARATOR

Placebo of DWJ1464

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DWJ1464

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

Intervention Type DRUG

Placebo of DWJ1464

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jae Young Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SoonChunHyang University Seoul Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DW_DWJ1464401

Identifier Type: -

Identifier Source: org_study_id