Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06746701

Study on the Treatment of Hepatitis B Virus(HBV) Infected Individuals With Peginterferon α-2b Combined With NA.

This is a retrospective prospective, open-label, multicenter clinical study aiming to recruit 400 individuals with a family history of liver cancer to explore the clinical cure rate and the effectiveness, feasibility, and safety of PEGylated interferon α-2b combined with nucleos(t)ide analogues in treating chronic HBV carriers with a family history of liver cancer for reducing the risk of liver cancer occurrence. Patients will enrolled into Group A (Peg-IFNα-2b combined with NA treatment group) or Group B (NA monotherapy group) based on their medication choices. Each group is expected to enroll 200 patients, with all patients followed up to 240 weeks. The dosage, frequency, and duration of treatment with Peg-IFN α-2b and NA will be prescribed by the researchers according to clinical practice and standard treatment protocols.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HBV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age18-65 years (inclusive of 18 and 65), no restriction on gender;
  • HBsAg positive history for at least 6 months;
  • Family history of liver cancer [including first-degree and second-degree relatives; first-degree relatives are parents, children, and siblings (same parents), while second-degree relatives are uncles, aunts, grandparents, and great-grandparents; a family history of liver cancer means that one or more first-degree or second-degree relatives have had liver cancer];
  • Planning to or already receiving treatment with Peginterferon alpha-2b in combination with nucleoside (acid) analogs, or receiving nucleoside (acid) analogs treatment alone;
  • Negative urine or serum pregnancy test within 24 hours before the first dose (for women of childbearing age);
  • Willing to receive treatment and sign an informed consent form.

Exclusion criteria

  • Allergy to interferon;
  • History of using telbivudine for antiviral treatment;
  • ALT(Alanine Aminotransferase) greater than 10 times the upper limit of normal, total bilirubin greater than 2 times the upper limit of normal;
  • Decompensated liver cirrhosis;
  • Neutrophil count < 1.5 x 10^9/L or platelet count < 80 x 10^9/L;
  • Presence of severe lesions in vital organs such as the cardiovascular, pulmonary, renal, brain, and fundus;
  • Those with autoimmune diseases, psychiatric disorders, poorly controlled diabetes, or thyroid dysfunction (hyperthyroidism or hypothyroidism);
  • Confirmed or suspected liver cancer or other malignant tumors;
  • Post-organ transplant or preparing for organ transplantation;
  • Currently using immunosuppressants;
  • Pregnant or planning to become pregnant within 2 years;
  • Alcohol or drug addicts;
  • HIV co-infection;
  • Other conditions deemed unsuitable for interferon use by the attending physician.

Treatment and study plan

Peg-IFNα-2b combined with NA

Drug

From baseline day 1, take NA orally once daily until the drug can be discontinued. Concurrently, combine with Peg-IFN α-2b 180μg, administered subcutaneously once a week for 48-96 weeks (if the surface antigen is not converted to negative at week 48, continue Peg-IFN α-2b treatment, but the course of treatment should not exceed 96 weeks). Discontinue Peg-IFN α-2b (while maintaining continuous oral administration of NA), and continue taking NA orally.

Nucleotide Analogues

Drug

Starting from the first day of enrollment, take NA orally once a day.

Primary outcomes

  1. Clinical cure rate

    Time frame: through study completion, an average of 24 weeks.

    The definition of a cure is: maintaining HBsAg(Hepatitis B surface antigen) negativity (with or without the appearance of anti-HBs), undetectable HBV DNA, normal liver biochemical indices, and improvement in liver tissue lesions after discontinuation of treatment.

  2. Liver cancer incidence rate

    Time frame: through study completion, an average of 24 weeks.

Secondary outcomes

  1. The decrease in HBsAg compared to baseline.

    Time frame: through study completion, an average of 24 weeks.

  2. HBsAg seroconversion rate

    Time frame: through study completion, an average of 24 weeks.

  3. Changes of biomarkers after disease progression-related markers such as HBV DNA quantification compared to baseline.

    Time frame: through study completion, an average of 24 weeks.

  4. Incidence of abnormal and clinically relevant changes in vital signs

    Time frame: through study completion, an average of 24 weeks.

  5. Incidence of treatment-emergent adverse event (AE)

    Time frame: through study completion, an average of 24 weeks.

  6. Incidence of abnormal and clinically relevant changes in laboratory assessments

    Time frame: through study completion, an average of 24 weeks.

  7. Incidence of severe acute allergic reactions occurring during treatment.

    Time frame: through study completion, an average of 24 weeks.

Study contacts

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

LeDu Zhou, Ph.D

CONTACT

[email protected]

17373120367

Lei Fu, Ph.D

CONTACT

[email protected]

0731-84327221

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Investigating the Clinical Cure Rate and the Risk Reduction of Hepatocellular Carcinoma in Chronic HBV Infected Individuals With a Family History of Liver Cancer Using PegIFN α-2b Combined With NA Treatment in a Real-world Study.

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Dec 24, 2024
Registry last updated
Dec 24, 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.