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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This is to evaluate the proportion of subjects who show good responses to LAM treatment in Korea.
This is to evaluate the proportion of subjects who show good responses to LAM treatment such as HBV DNA negativity, HBV DNA less than 4 log, no resistant mutation, HBeAg seroconversion and normalization of ALT in naïve CHB patients with certain pre-treatment characteristics, i.e. HBV DNA less than 9log copies per ml and ALT more than 2 times ULN in HBeAg positive subjects, HBV DNA less than 7log copies per ml and elevated ALT in HBeAg negative subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHB patients who started LAM as an initial antiviral treatment | CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This study is retrospective chart review |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects showing HBV DNA negativity at 5 years of LAM treatment | 5years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects showing HBV DNA negativity during first 4 years of LAM treatment | 4 years | |
| Proportion of subjects showing HBV DNA less than 4 log copies per ml during 5 years of LAM treatment | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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CHB patients who started LAM as an initial antiviral treatment at least 5 years prior to this investigation in General Hospital
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kangwon-do | 220-701 | 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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| Cumulative proportion of subjects showing HBeAg seroconversion during 5 years of LAM treatment | 5 years |
| Cumulative proportion of subjects showing HBeAg loss during 5 years of LAM treatment | 5 years |
| Proportion of subjects showing ALT normalization during 5 years of LAM treatment | 5 years |
| Cumulative proportion of subjects showing resistant mutation during 5 years of LAM treatment | 5 years |
| 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 |