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This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon α-2b based group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon α-2b based injection | Drug | Peginterferon α-2b injection, 180 μg administered subcutaneously in the abdomen or thigh once weekly, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intrahepatic cccDNA and peripheral blood pgRNA levels | baseline to week48 | |
| Clearance rate of intrahepatic cccDNA | week48 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy | baseline to week48 | |
| Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy | baseline to week48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqing Liang, Ph.D | Contact | 13306051108 | 13306051108@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiqing Liang, Ph.D | Xiamen Hospital of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | Fujian | 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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| Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy | week48 |
| Changes in intrahepatic cccDNA levels | baseline to week48 |
| Changes in intrahepatic HBsAg levels | baseline to week48 |
| intrahepatic HBsAg clearance rate | baseline、week48 |
| Histopathological scores in hepatic inflammation and fibrosis | baseline、week48 |
| Recurrence rate | baseline to week48 |
| Adverse Event#AE# | baseline to week48 |
| 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 |