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This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
This study is a real-world case-control study conducted on 120 patients with chronic hepatitis B (CHB) who were continuously treated with pegylated interferon-α (PEG-IFN-α) for more than 24 weeks. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B with PEG-IFN-α therapy, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Case group (HBsAg negative conversion group): 120 CHB patients who achieved clinical cure after continuous treatment with PEG-IFN-α for more than 24 weeks. |
| |
| Control group | Control group: 300 CHB patients who were continuously treated with PEG-IFN - α for more than 24 weeks without clinical cure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-IFN-α | Drug | chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT\ | 96 weeks |
| Non clinical cure | Non clinical cure (partially effective and ineffective): HBsAg has not turned negative Partially effective: HBV DNA is below the lower limit of detection, ALT is below the lower limit of normal. Invalid: Not partially valid. | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBV DNA turns negative | HBV DNA suppression (HBV DNA below the detection limit or not detected); | 96 weeks |
| HBeAg conversion to negative | HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity). |
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Inclusion Criteria:
Exclusion Criteria:
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Collect blood samples from CHB patients who have completed PEG-IFN - α continuous treatment for more than 24 weeks (two groups of CHB patients who have obtained and have not obtained clinical cure after PEG-IFN - α treatment), to provide samples for sequencing candidate genes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weihua Cao, Dr | Contact | 18811333129 | weihuacaohappy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | 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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Collect blood samples as candidate gene sequencing samples, use high-throughput sequencing technology to detect the whole genome of the subjects, identify relevant gene loci that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN - α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN - α antiviral therapy.
| 96 weeks |
| HBsAg re positivity rate | Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal | 96 weeks |
| Improvement in liver function | Liver function status after PEG-IFN-α treatment | 96 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 |