Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B

Conditions
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HBeAg-Positive Chronic Hepatitis B

Intervention / Treatment
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* Drug: Baracle Tab.®
* Drug: Baraclude Tab.®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baracle Tab.®<br>(It can be also placebo) dosage: 2 tablets daily for 48 weeks | Drug: Baracle Tab.®<br> <br> |
| Experimental: Baraclude Tab.®<br>(It can be also placebo) dosage: 2 tablets daily for 48 weeks | Drug: Baraclude Tab.®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10) | measured at 24th week of the administration | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre) | measured at 24th/48th week of the administration | 52 weeks | 
| the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal) | measured at 24th/48th week of the administration | 52 weeks | 
| the percentage of participants who have lost HBeAg | HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration. | 52 weeks |