Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
Location status: Recruiting
NCT Number: NCT06696664
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Beijing, Beijing Municipality, 100015, China
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks
Time frame: 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
Time frame: 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.
Time frame: 96 weeks
HBV DNA suppression (HBV DNA below the detection limit or not detected);
Time frame: 96 weeks
HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity).
Time frame: 96 weeks
Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal
Time frame: 96 weeks
Liver function status after PEG-IFN-α treatment
Contact information is provided by the study sponsor or research team.
Minghui Li
Other Gov
Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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