Chronic Hepatitis B
Conditions
Keywords
chronic hepatitis B, pegylated interferon-α, clinical cure, gene sequencing, genetic polymorphism
Brief summary
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.
Detailed description
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.
Interventions
DRUGPEG-IFN-α
chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks
Sponsors
Minghui Li
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* 18 years old ≤ age ≤ 70 years old, Han ethnicity, gender not limited; * According to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022), patients with HBsAg and/or HBV DNA positivity for more than 6 months and chronic inflammatory liver disease caused by persistent HBV infection are diagnosed with chronic hepatitis B (CHB); * The patient receives subcutaneous injections of PEG-IFN-α for at least 24 consecutive weeks; * Patients voluntarily sign an informed consent form before the start of the study.
Exclusion criteria
* Patients with co infection of HCV, HDV, HIV, and Treponema pallidum; * Patients with evidence of alcohol abuse, decompensated cirrhosis, liver tumors (liver cancer or AFP\>100 ng/ml), or autoimmune diseases. * Patients who become pregnant during PEG-IFN - α treatment; * Other situations that the patient deems unsuitable for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure | 96 weeks | HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT\<lower limit of normal value |
| Non clinical cure | 96 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA turns negative | 96 weeks | HBV DNA suppression (HBV DNA below the detection limit or not detected); |
| HBeAg conversion to negative | 96 weeks | HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity). |
| HBsAg re positivity rate | 96 weeks | Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal |
| Improvement in liver function | 96 weeks | Liver function status after PEG-IFN-α treatment |
Countries
China
Contacts
Primary ContactWeihua Cao, Dr
Outcome results
None listed