Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location status: Recruiting

Location contact

Minghui Li, Dr

CONTACT

[email protected]

+8613693259096

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peg-IFN-α

Drug

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

Primary outcomes

  1. Clinical cure

    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

  2. Non clinical cure

    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.

Secondary outcomes

  1. HBV DNA turns negative

    Time frame: 96 weeks

    HBV DNA suppression (HBV DNA below the detection limit or not detected);

  2. HBeAg conversion to negative

    Time frame: 96 weeks

    HBeAg conversion to negative (disappearance of HBeAg in patients with previous HBeAg positivity).

  3. HBsAg re positivity rate

    Time frame: 96 weeks

    Hepatitis B surface antigen re positive rate after PEG-IFN-α withdrawal

  4. Improvement in liver function

    Time frame: 96 weeks

    Liver function status after PEG-IFN-α treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Weihua Cao, Dr

CONTACT

[email protected]

18811333129

Sponsors and collaborators

Lead sponsor

Minghui Li

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

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.

Published trials that share one or more normalized conditions with this study.