Back to resultsClinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Primary Purpose
Hepatitis B
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-2803
DA-2803-R
Placebo of DA-2803
Placebo of DA-2803-R
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria: Adult male and female subjects of ages in the range over 19 The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent Exclusion Criteria: The subjects who have been infected with HCV, HDV, HIV The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma
Sites / Locations
- The Catholic University of Korea, SeoulRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment group
Reference group
Arm Description
Outcomes
Primary Outcome Measures
HBV DNA(log10 IU/mL) change
HBV DNA(log10 IU/mL) change compared to baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05957380
Brief Title
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Official Title
A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a multi-center, double-blind, active-controlled, randomized, parallel clinical study to evaluate the efficacy and safety of DA-2803 in chronic hepatitis B subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Title
Reference group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DA-2803
Intervention Description
All participants are administered one tablet per day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
DA-2803-R
Intervention Description
All participants are administered one tablet per day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of DA-2803
Intervention Description
All participants are administered one tablet per day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of DA-2803-R
Intervention Description
All participants are administered one tablet per day for 48 weeks
Primary Outcome Measure Information:
Title
HBV DNA(log10 IU/mL) change
Description
HBV DNA(log10 IU/mL) change compared to baseline
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male and female subjects of ages in the range over 19
The subjects HBsAg positive for at least 6 months or has history of Chronic Hepatitis B
The subjects whose HBV DNA above 20,000 IU/mL when HBeAg positive or above 2,000 IU/mL when HBeAg negative or positive when has history of Chronic Hepatitis B
The subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent
Exclusion Criteria:
The subjects who have been infected with HCV, HDV, HIV
The subjects who have Hemochromatosis, Wilson's disease, autoimmune liver disease, and α-1 antitrypsin deficiency
The subjects whose α-fetoprotein over 50 ng/mL and who are persumed to be Hepatocelluar carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeongwon Jang
Phone
82-1588-1511
Email
garden@catholic.ac.kr
Facility Information:
Facility Name
The Catholic University of Korea, Seoul
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
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