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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EntecaBell ODT. | Experimental |
| |
| Baraclude Tab. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EntecaBell ODT. 0.5mg | Drug |
| ||
| Baraclude Tab. 0.5mg |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of subjects who showed HBV DNA undetected (less than 300copies/mL) | 48 week |
| 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 | |
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Inclusion Criteria:
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
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dankook University Hospital | Cheonan | Chungcheongnam-do | South Korea | |||
| Chungnam National University Hospital |
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|
| 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 |
| Daejeon |
| Chungcheongnam-do |
| South Korea |
| Kyungpook National University Hospital | Daegu | Gyeong Sangbuk-do | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyeonggi-do | South Korea |
| Yeungnam University Hospital | Daegu | Gyeongsangbuk-do | South Korea |
| Jeju National University Hospital | Jeju City | Jeju-do | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
| Chonnam National University Hospital | Gwangju | Jeollanam-do | South Korea |
| Konkuk University Chungju Hospital | Chungju | North Chungcheong | South Korea |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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