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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized to one of the 2 groups to receive different antiviral treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Ypeginterferon alfa-2b,sc. Qw. 48 weeks. |
|
| Arm B | Experimental | Ypeginterferon alfa-2b,sc. Qw. 48 weeks. Granulocyte-macrophage colony stimulating factor,sc.qd, the first three day of every 28 days, starting from interferon treatment week 13. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ypeginterferon alfa-2b | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HBeAg seroconversion at the end of treatment | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HBsAg undetectable and seroconversion at the end of treatment | week 48 | |
| Percentage of HBeAg undetectable and seroconversion at week 12, 24, 36 and 48 | week 12, 24, 36 and 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China | |||
| Peking University People's Hosopital |
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| Granulocyte-macrophage colony stimulating factor |
| Drug |
|
|
| Change of HBsAg and HBeAg from baseline at week 12, 24, 36, and 48 |
| week 12, 24, 36, and 48 |
| Change of HBV DNA from baseline and percentage of HBV DNA undetectable at week 12, 24, 36, and 48 | treatment week 12, 24, 36, and 48 |
| Percentage of ALT normalization at week 24, 36 and 48 | week 24 ,36 and 48 |
| Beijing |
| Beijing Municipality |
| China |
| Fuzhou Infectious Disease Hospital | Fuzhou | Fujian | China |
| Xiamen Hospital of T.C.M | Xiamen | Fujian | China |
| Nanfang Hospital | Guangzhou | Guangdong | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | China |
| Tongji Hospital, Huazhong University of Science & Technology | Wuhan | Hubei | China |
| Xiangya Second Hospital, Central-south University | Changsha | Hunan | China |
| Shenyang Sixed People's Hospital | Shenyang | Liaoning | China |
| Ruijing Hospital | Shanghai | Shanghai Municipality | China |
| Xijing Hospital | Xi’an | Shanxi | China |
| First Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D003115 | Colony-Stimulating Factors |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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