HBeAg-Positive Chronic Hepatitis B
Conditions
Brief summary
This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.
Interventions
DRUGBaracle Tab.®
DRUGBaraclude Tab.®
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit * Subjects with HBsAg-Positive diagnosed at the screening visit * Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit * For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10\^5 copies/ml * For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10\^5 copies/ml * Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon
Exclusion criteria
* Subjects with HCV, HDV or HIV * Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin * With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein * Less than 50ml/min of creatinine clearance diagnosed at the screening visit * More than 50 ng/ml of alpha-fetoprotein at the screening visit * Involved in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10) | 52 weeks | measured at 24th week of the administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre) | 52 weeks | measured at 24th/48th week of the administration |
| the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal) | 52 weeks | measured at 24th/48th week of the administration |
| the percentage of participants who have lost HBeAg | 52 weeks | HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration. |
Countries
South Korea
Outcome results
None listed