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This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Serum Albumin/interferon alpha2a | Experimental | Human Serum Albumin/interferon alpha2a 600,750 or 900 mcg multiple dose S.C. |
|
| Pegasys | Active Comparator | Peginteferon 180 mcg multiple dose S.C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Serum ALbumin/interferon alpha2a | Biological | 600,750 or 900 mcg dosing every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease of HBV DNA | 18 weeks | |
| AUCss | 18 weeks | |
| Css_av |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Junqi Niu, MD | Jilin University First Affiliated Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin University First Affiliated Hospital | Changchun | Jilin | 130021 | China |
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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 |
|---|---|
| D000075462 | Serum Albumin, Human |
| D000077190 | Interferon alpha-2 |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012709 | Serum Albumin |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Pegasys | Biological | 180 mcg dosing every week |
|
| 18 weeks |
| Css_min | 18 weeks |
| Css-max | 18 weeks |
| T1/2 | 18 weeks |
| Tmax | 18 weeks |
| 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 |
| D001798 |
| Blood Proteins |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |