Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272630
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-26
First Post:
2023-04-06
Brief Title:
Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients With Chronic Liver Disease
Sponsor:
Daewoong Pharmaceutical Co LTD
Organization:
Daewoong Pharmaceutical Co LTD
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None