Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: EntecaBell ODT. 0.5mg
* Drug: Baraclude Tab. 0.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 20 years old Patients with Chronic Hepatitis B diagnosed Patients who show positive HBsAg Patients who show positive HBeAg or negative HBeAg Patients who showed HBV DNA undetected(less than 300 copies/mL) Patients who have administered Baraclude Tab. 0.5mg for 1 4 years Patients who showed ALT less than 5 times of the upper limit in the normal range Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV) Patients with a uncompensated liver disease who have at least one of the following values or signs Total bilirubin > 2.5mg/dl Prothrombin time delayed more than three seconds of upper limit in the normal range Serum Albumin < 3 g/dL A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir) Administration of other Investigational Product within 30 days History of malignant tumor within 5 years (including leukemia and lymphoma) Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial Patients who have other hepatic diseases except hepatitis B Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial Pregnant, breast-feeding and childbearing age who don't use adequate contraception Patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial Patients who received an organ transplant or are going to received an organ transplant Severe hypersensitivity to Entecavir Another clinical condition in investigator's judgement

Ages Eligible for Study
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Minimum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EntecaBell ODT.<br> | Drug: EntecaBell ODT. 0.5mg<br> <br> |
| Active Comparator: Baraclude Tab.<br> | Drug: Baraclude Tab. 0.5mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) |  | 48 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) |  | 24 week | 
| The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10) |  | 24, 48 week | 
| The rate of subjects who showed HBeAg serum loss |  | 24, 48 week | 
| The rate of subjects who showed HBeAg seroconversion |  | 24, 48 week | 
| The rate of subjects who showed HBsAg serum loss |  | 48 week | 
| The rate of subjects who showed HBsAg seroconversion |  | 48 week | 
| The rate of subjects who showed Virologic breakthrough |  | 12, 24, 48 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Entecavir, EntecaBell ODT., Hepatitis B