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The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein injection on HBV subjects.
This is an open-label study that will be conducted at three sites in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Serum Albumin/interferon alpha2b | Experimental | Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks. |
|
| Pegasys | Active Comparator | Pegasys 180 mcg, once per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Serum Albumin/interferon alpha2b fusion protein | Biological | In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period. |
| Measure | Description | Time Frame |
|---|---|---|
| the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment | HBV DNA | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment | HBV DNA | 4 weeks and 17 weeks |
| the recovery rates of ALT after treatment | ALT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| meixia wang, professor | Beijing YouAn Hospital | Principal Investigator |
| jun li, professor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| liang chen, professor | Shanghai Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing YouAn Hospital, Capital Medical University | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C543152 | human serum albumin-interferon-alpha-2b fusion protein |
| C100416 | peginterferon alfa-2a |
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| Pegasys | Biological | In comparator group, each subject will recieve 180mcg once per week. |
|
| 17 weeks |
| the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment | HBsAg/HBeAg | 17 weeks |
| the rates of HBsAg decrease from baseline after treatment | HBsAg | 17 weeks |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |