Hepatitis B， Chronic
Conditions
Brief summary
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
Detailed description
1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks. 2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.
Interventions
DRUGDA-2802
DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
DRUGViread®
Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic hepatitis B aged 18 years or older * Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit * Subjects who have HBsAg positive test at screening visit * Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test * Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening
Exclusion criteria
* Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus * Subjects with creatinine clearance of less than 50 ml/min at the screening visit * At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma * Subjects with decompensated liver disease who meet the following criteria: 1. Total bilirubin levels greater than 2.5 mg/dl 2. Prothrombin time is at least 3 seconds longer than normal upper limit 3. Serum albumin value less than 30 g/l 4. Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of HBV DNA level(log10) | Change from baseline at 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects HBV DNA < 400 copies/ml | at 24 weeks, 48 weeks |
| Percentage of subjects who had normal ALT levels | at 24 week, 48 week |
| Percentage of subjects who experienced loss of HBeAg | at 24 week, 48 week |
Countries
South Korea
Outcome results
None listed