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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baracle Tab.® | Experimental | (It can be also placebo) dosage: 2 tablets daily for 48 weeks |
|
| Baraclude Tab.® | Experimental | (It can be also placebo) dosage: 2 tablets daily for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baracle Tab.® | Drug |
| ||
| Baraclude Tab.® |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Chu Lee, M.D. | Asan Medical Center | Principal Investigator |
| Si Hyun Bae, M.D | The Catholic University of Korea | Principal Investigator |
| Ju Hyun Kim, M.D. | Gachon University of Medicine and Science Gil Medical Center | Principal Investigator |
| Jae Seok Hwang, M.D. | Keimyung University Dongsan Medical Center | Principal Investigator |
| So Young Kwon, M.D. | Konkuk University Hospital | Principal Investigator |
| Won Young Tak | Kyunpook National University Hospital | Principal Investigator |
| Jong Eun Yeon, M.D. | Korae University Guro Hospital | Principal Investigator |
| Sang Young Han, M.D. | Dong-A University Hospital | Principal Investigator |
| Joon Hyouk Lee, M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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|
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 |
| Jung Hwan Yoon, M.D. |
| Seoul National University Hospital |
| Principal Investigator |
| Sang Hoon Ahn, M.D. | Severance Hospital | Principal Investigator |
| Neung Hwa Park, M.D. | Ulsan University Hospital | Principal Investigator |
| Youn Jae Lee, M.D. | Inje University | Principal Investigator |
| In Hee Kim, M.D. | Chonbuk National University Hospital | Principal Investigator |
| Byung Seok Lee, M.D. | Chungnam National University Hospital | Principal Investigator |