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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)
Secondary objective :
The changes of HBsAg titer
The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL
The rate of serum HBV DNA < 300 copies/mL â…³. The rate of ALT normalization
After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBsAg quantification>20,000 IU/ml | Sham Comparator | stop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w |
|
| HBsAg<=1500IU/ml | Sham Comparator | extend peginterferon alfa 2a until 48weeks |
|
| HBsAg >1500 <=20,000 IU/ML | Sham Comparator | add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | Duration and combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBeAg seroconversion | 24 weeks post treatment follow up |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of HBsAg titer | baseline and 24weeks post treatment follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kwansik Lee, professor | Contact | +82 11 9636 9935 | leeks519@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Kwansik Lee, professor | Gangnam Severance Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shinchon Severance Hospital | Recruiting | Seoul | Seoul | 120742 | 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 |
|---|---|
| C100416 | peginterferon alfa-2a |
| C413685 | entecavir |
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| Entecavir | Drug | combination |
|
|
| 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 |