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Development and Validation of Models to Predict Functional Cure in Patients With CHB After Peg-IFN Based Therapy

NCT06196632 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-02-07

No results posted yet for this study

Summary

Hepatitis B virus (HBV) infection is prevalent across the world. Functional cure is the optimal endpoint of antiviral therapy for chronic hepatitis B virus (HBV) infection. Currently available anti-HBV therapy includes nucleoside analogs (NAs) and peginterferon-α (Peg-IFNα). Combination of Peg-IFNα and NAs, each with different mechanisms of action, is an attractive approach for treating chronic HBV infection. In this study, we aim to establish logistic regression models to predict durable functional cure in patients with CHB treated by combination of Peg-IFNα and NAs, which might be useful for clinical physicians to make personalized treatment decisions. These models will be constructed using baseline routine clinical laboratory indicators with high diagnostic accuracy. These models might be widely applicable to almost all medical institutions and will effectively promote the application of Peg IFN α plus NAs therapy in clinical work. The findings in this study might greatly improve the functional cure rate of CHB and reducing the incidence rate and mortality of HBV related end-stage liver diseases.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Peginterferon-α; Nucleoside analogs

Patients with chronic hepatitis B were treated with the combination of peginterferon-α and nucleoside analogs

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-06
Primary Completion
2024-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06196632 on ClinicalTrials.gov