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NCT Number: NCT07007286

Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer

This study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis B patients with a family history of HBV-related hepatocellular carcinoma (HCC) who receive PEG IFNα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. The primary endpoint is the incidence rate of HCC, and secondary endpoints include the rate of HBsAg seroclearance, changes in liver fibrosis, and survival rates. The study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for CHB treatment regimens.

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Key information

Conditions

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qitaihe Infectious Disease Hospital, Heilongjiang, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (1) Chronic hepatitis B (CHB) patients with HBsAg positivity for over 6 months; (2) Family history of HBV-related hepatocellular carcinoma (HCC) (first- or second-degree relatives with HBV-related HCC); (3) Age ≥ 30 years, regardless of gender; (4) Based on real-world clinical practice, patients receiving nucleos(t)ide analogue (NA) therapy, such as Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide Fumarate (TAF), or Tenofovir Amibufenamide (TMF), or those receiving combination therapy with nucleos(t)ide analogues and PEG IFNα-2b; (5) Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) Voluntary participation, with the ability to understand and sign the informed consent form.

Exclusion criteria

  • (1) Patients diagnosed with hepatocellular carcinoma (HCC) or malignancies in other organ systems prior to treatment; (2) Patients with contraindications to Peg IFN α-2b (refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) for details); (3) Patients in the immune-tolerant phase of HBV infection; (4) Patients scheduled for or with a history of organ transplantation; (5) Patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) Other conditions deemed unsuitable for enrollment by the investigator.

Treatment and study plan

ETV,TDF,TAF,TMF combination with PEG IFNα-2b

Drug

The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

ETV,TDF,TAF or TMF

Drug

The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.

Primary outcomes

  1. 5-year incidence of hepatocellular carcinoma (HCC)

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

Secondary outcomes

  1. HBsAg seroclearance rate

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  2. HBeAg seroclearance rate

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  3. HBV DNA level

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  4. HBsAg level

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  5. HBeAg level

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  6. Proportion of patients with improved or progressed liver fibrosis

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  7. Median time to cirrhosis

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  8. Median time to decompensated cirrhosis

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  9. Median time to HCC

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

  10. Overall survival (OS)

    Time frame: From the start of antiviral treatment to 5 years of follow-up.

Study contacts

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

Guiqiang Wang

CONTACT

[email protected]

01066119025

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

A Real-World Study on Reducing the Risk of Liver Cancer in Chronic Hepatitis B Patients With a Family History of HBV-Related Liver Cancer.

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

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.

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