Hepatitis B
Conditions
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
Interventions
DRUGPlacebo of DA-2803
All participants are administered one tablet per day for 48 weeks
DRUGDA-2803
All participants are administered one tablet per day for 48 weeks
DRUGDA-2803-R
All participants are administered one tablet per day for 48 weeks
DRUGPlacebo of DA-2803-R
All participants are administered one tablet per day for 48 weeks
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA(log10 IU/mL) change | 48 weeks | HBV DNA(log10 IU/mL) change compared to baseline |
Countries
South Korea
Outcome results
None listed