Chronic Liver DiseasePhase 4NCT06272630
Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
A Phase 4 study testing DWJ1464 in people with Chronic Liver Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- DWJ1464
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2023to 29 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- DWJ1464, Placebo of DWJ1464
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1464Drug
DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
Placebo of DWJ1464Drug
Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week
| Study group | Role | What they receive |
|---|---|---|
| DWJ1464 | Experimental | UCDA 100 mg, TID Receives: Drug: DWJ1464 |
| Placebo of DWJ1464 | Placebo comparator | Placebo of DWJ1464, TID Receives: Drug: Placebo of DWJ1464 |
What is being measured
The primary outcome is the main question the study is designed to answer.
At 8 weeks, the change of ALT level compared to baseline
Measured: 8 weeks after randomization
Secondary outcomes (6)
At 4 weeks, the change of ALT level compared to baseline
Measured: 4 weeks after randomization
At 4, 8 weeks, the change of AST level compared to baseline
Measured: 4, 8 weeks after randomization
At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline
Measured: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibrotest compared to baseline
Measured: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibroscan compared to baseline
Measured: 4, 8 weeks after randomization
At 4, 8 weeks, the change of K-CFQ(Korean version of Chalder Fatigue Scale) scores, compared to the baseline
Measured: 4, 8 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start6 Feb 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Young Jang, MD, PhD, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272630
- Sponsor's protocol ID
- DW_DWJ1464401
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chang Y, Cho YK, Kim YS, Kim SE, Cheon GJ, Kim JH, Yang H, Kim W, Ahn SB, Yoon EL, Cheong JY, Lee JW, Kim MY, Kim HJ, Lee SH, Cho EY, Choi NR, Lee HW, Kim KM, Choe WH, Yu JM, Kim SY, Jang JY. Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Korean Med Sci. 2026 May 18;41(19):e89. doi: 10.3346/jkms.2026.41.e89.
PubMed 42153228
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06272630
- Acronym / sponsor ID
- DW_DWJ1464401
- Conditions
- Chronic Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWJ1464 | Experimental | Drug: DWJ1464UCDA 100 mg, TID |
| Placebo of DWJ1464 | Placebo comparator | Drug: Placebo of DWJ1464Placebo of DWJ1464, TID |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWJ1464DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week | Drug | DWJ1464 |
| Placebo of DWJ1464Placebo of DWJ1464, TID, Duration of administration: 8 weeks, Visit: every 4 week | Drug | Placebo of DWJ1464 |
Primary outcome
At 8 weeks, the change of ALT level compared to baseline
Time frame: 8 weeks after randomization
6 secondary outcomes
At 4 weeks, the change of ALT level compared to baseline
Time frame: 4 weeks after randomization
At 4, 8 weeks, the change of AST level compared to baseline
Time frame: 4, 8 weeks after randomization
At 4, 8 weeks, the change of liver function comparator GGT level compared to baseline
Time frame: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibrotest compared to baseline
Time frame: 4, 8 weeks after randomization
At 8 weeks, the change of liver function comparator Fibroscan compared to baseline
Time frame: 4, 8 weeks after randomization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 42153228Chang Y, Cho YK, Kim YS, Kim SE, Cheon GJ, Kim JH, Yang H, Kim W, Ahn SB, Yoon EL, Cheong JY, Lee JW, Kim MY, Kim HJ, Lee SH, Cho EY, Choi NR, Lee HW, Kim KM, Choe WH, Yu JM, Kim SY, Jang JY. Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Korean Med Sci. 2026 May 18;41(19):e89. doi: 10.3346/jkms.2026.41.e89.
- Individual participant dataSharing planned: Undecided
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Liver Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Young Jang, MD, PhD principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DWJ1464 in people with Chronic Liver Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At 8 weeks, the change of ALT level compared to baseline (time frame: 8 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06272630, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.