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RecruitingNCT06196632Updated Feb 7, 2024

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

An observational study in Hepatitis B, Chronic, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Qilu Hospital of Shandong University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,000
Ages
16 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The participants were retrospectively enrolled from more than 10 hospitals in China.

Inclusion criteria

    1. Sign an informed consent form;
    1. HBsAg (+), and the course of the disease exceeds six months;
    1. Age range from 16 to 70 years old;
    1. Female participants of childbearing age who had a negative pregnancy test before the trial and were able to take effective contraceptive measures;
    1. During the treatment period, within six months after the end of treatment, the patients agrees to use contraception

Exclusion criteria

Exclusion Criteria:

    1. Patients with a known history of allergy to Peg-IFNα and NAs;
    1. Co-infection with other virus such as HAV, HCV, HDV, HEV, HIV, etc;
    1. Patients with liver cirrhosis or a Child Pugh score of 7 or above;
    1. History or evidence of liver disease caused by other factors (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.);
    1. Pregnant or lactating women; Have a history of alcohol or drug abuse within the year prior to the trial enrollment screening;
    1. Neutrophil count\<1.5 × 109/L or hemoglobin\<100g/L or platelet count\<80 × 109/L; During the trial enrollment screening, serum creatinine was higher than the upper normal limit;
    1. A history of severe diseases in important organs and tissues such as the heart, brain, kidneys, retina, and muscles;
    1. Having a history of mental illness or a family history of mental illness, or a Hamilton Depression Scale score greater than 7 points;
    1. History of endocrine system or autoimmune diseases, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc;
    1. History of malignant tumors;
    1. During the trial enrollment screening, suspicious liver malignant tumors were detected by ultrasound, or AFP was greater than 100ng/mL or AFP cannot remain stable within 3 months prior to the experiment;
    1. Has a history of important organ transplantation;
    1. Other diseases that researchers believe are not suitable for inclusion.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • "de novo" strategy-HBeAg positive

    HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN

    Drug: Peginterferon-α; Nucleoside analogs

  • "de novo" strategy-HBeAg negative

    HBeAg positive patients treated with simultaneous administration of NA and Peg-IFN

    Drug: Peginterferon-α; Nucleoside analogs

  • "add-on" strategy-HBeAg positive

    HBeAg positive patients treated with NA followed by addition of Peg-IFN.

    Drug: Peginterferon-α; Nucleoside analogs

  • "add-on" strategy-HBeAg negative

    HBeAg negative patients treated with NA followed by addition of Peg-IFN.

    Drug: Peginterferon-α; Nucleoside analogs

Interventions

  • DrugPeginterferon-α; Nucleoside analogs

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

06

What researchers measure

Primary outcomes

  1. Functional cure of chronic hepatit B

    The level of hepatitis B surface antigen (HBsAg) is below 0.05IU/ml.

    Time frame: 48 weeks

07

Study locations

1 of 1 sites recruiting
  • Qilu hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06196632
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
Jan 9, 2024
Start date
Jan 6, 2024
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Feb 7, 2024

Study contacts

Shuai Gao, MD;PhD
Contact
qilugaoshuai@sdu.edu.cn
+86-18560088213

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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