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

NCT06272630 | Completed Phase 4

• 1 other identifier: DW_DWJ1464401
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

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

  8 weeks after randomization

Secondary Outcomes (6)

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

  4 weeks after randomization

• 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 8 weeks, the change of liver function comparator Fibroscan compared to baseline

  4, 8 weeks after randomization

Study Arms (2)

DWJ1464

EXPERIMENTAL

UCDA 100 mg, TID

Drug: DWJ1464

Placebo of DWJ1464

PLACEBO COMPARATOR

Placebo of DWJ1464, TID

Drug: Placebo of DWJ1464

Interventions

DWJ1464 DRUG

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

DWJ1464

Placebo of DWJ1464 DRUG

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

Placebo of DWJ1464

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

SoonChunHyang University Seoul Hospital

Seoul, 04401, South Korea

Location

Study Officials

• Jae Young Jang, MD, PhD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: February 22, 2024
• Study Start: February 6, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

KR (1)