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Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cavir | Experimental | entecavir/0.5mg/day |
|
| Baraclude | Active Comparator | entecavir/0.5mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cavir | Drug | 0.5mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with maintenance of HBV DNA undetectability | analysis | 48weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with HBeAg seroconversion | analysis | at week 12, 24, 36 and 48 of treatment |
| The proportion of patients with HBeAg seroclearance | analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanmi Pharmaceutical | Contact | |||
| EunSol Kim | Contact | +82-2-410-8747 | snow-white@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 15 Sites | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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| Baraclude |
| Drug |
0.5mg/day |
|
|
| at week 12, 24, 36 and 48 of treatment |
| The proportion with HBsAg seroclearance | analysis | at week 48 of treatment |
| The proportion with HBeAg seroconversion and HBsAb positive | analysis | at week 48 of treatment |
| Changes in serum HBV DNA levels | analysis | at week 48 of treatment |
| Changes in HBsAg titer | analysis | at week 48 of treatment |
| Changes in ALanine amino Transferase (ALT) | analysis | at week 48 of treatment |
| Proportion of patients with virologic breakthrough | virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment | at week 48 of treatment |
| Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L) | questionnaire | at week 48 of treatment |
| 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 |