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Completed

NCT Number: NCT06272630

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

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.

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Key information

Conditions

Chronic Liver Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SoonChunHyang University Seoul Hospital

Seoul, 04401, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWJ1464

Drug

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

Placebo of DWJ1464

Drug

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

Primary outcomes

  1. At 8 weeks, the change of ALT level compared to baseline

    Time frame: 8 weeks after randomization

Secondary outcomes

  1. At 4 weeks, the change of ALT level compared to baseline

    Time frame: 4 weeks after randomization

  2. At 4, 8 weeks, the change of AST level compared to baseline

    Time frame: 4, 8 weeks after randomization

  3. At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline

    Time frame: 4, 8 weeks after randomization

  4. At 8 weeks, the change of liver function comparator Fibrotest compared to baseline

    Time frame: 4, 8 weeks after randomization

  5. At 8 weeks, the change of liver function comparator Fibroscan compared to baseline

    Time frame: 4, 8 weeks after randomization

  6. At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline

    Time frame: 4, 8 weeks after randomization

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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