Clinical trial NCT06696664: Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon
Official title: Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
pegylated interferon-α
clinical cure
gene sequencing
genetic polymorphism
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
First posted: 2024-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical cure
timeFrame: 96 weeks
measure: Non clinical cure
timeFrame: 96 weeks
Secondary outcomes:
measure: HBV DNA turns negative
timeFrame: 96 weeks
measure: HBeAg conversion to negative
timeFrame: 96 weeks
measure: HBsAg re positivity rate
timeFrame: 96 weeks
measure: Improvement in liver function
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
References: