Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Phase 4
Completed
- Conditions
- Hepatitis B
- Interventions
- Registration Number
- NCT05957380
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group DA-2803 - Treatment group Placebo of DA-2803-R - Reference group DA-2803-R - Reference group Placebo of DA-2803 -
- Primary Outcome Measures
Name Time Method HBV DNA(log10 IU/mL) change 48 weeks HBV DNA(log10 IU/mL) change compared to baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Catholic University of Korea, Seoul
🇰🇷Seoul, Korea, Republic of