Exploring the Genome-wide Association Study of the Population With Clinical Cure Advantage in the Treatment of Chronic Hepatitis B With Long-acting Interferon

NCT06696664 | Recruiting

• 1 other identifier: BTP-CHB04
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B; pegylated interferon-α; clinical cure; gene sequencing; genetic polymorphism

Outcome Measures

Primary Outcomes (2)

• Clinical cure

  HBsAg negative, with or without the presence of anti HBs, HBV DNA below the lower limit of detection, ALT\<lower limit of normal value

  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

Secondary Outcomes (4)

• HBV DNA turns negative

  96 weeks

• HBeAg conversion to negative

  96 weeks

• HBsAg re positivity rate

  96 weeks

• Improvement in liver function

  96 weeks

Study Arms (2)

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.

Drug: PEG-IFN-α

Control group

Control group: 300 CHB patients who were continuously treated with PEG-IFN - α for more than 24 weeks without clinical cure.

Drug: PEG-IFN-α

Interventions

PEG-IFN-α DRUG

chronic hepatitis B (CHB) who were continuously treated with pegylated interferon (PEG-IFN - α) for more than 24 weeks

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Minghui Li: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Weihua Cao, Dr

CONTACT

18811333129; weihuacaohappy@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 96 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Professor

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: August 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)