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Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
View:

• 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.

Locations
Other Locations
China
Beijing Ditan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Weihua Cao, Dr
weihuacaohappy@163.com
18811333129
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Minghui Li

This content was sourced from clinicaltrials.gov