Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ETV,TDF,TAF,TMF combination with PEG IFNα-2b, ETV,TDF,TAF or TMF.
- Who it may be relevant to
- Registry conditions: HBV, HCC. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Drug ETV,TDF,TAF,TMF combination with PEG IFNα-2b
The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making. - Drug ETV,TDF,TAF or TMF
The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.
Primary outcome measures
- 5-year incidence of hepatocellular carcinoma (HCC) [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
Secondary outcome measures (10)
- HBsAg seroclearance rate [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- HBeAg seroclearance rate [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- HBV DNA level [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- HBsAg level [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- HBeAg level [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- Proportion of patients with improved or progressed liver fibrosis [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- Median time to cirrhosis [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- Median time to decompensated cirrhosis [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- Median time to HCC [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
- Overall survival (OS) [Time frame: From the start of antiviral treatment to 5 years of follow-up.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 555 centers
- Qitaihe Infectious Disease Hospital — Heilongjiang
- Yizheng People's Hospital — Yizheng
- Changle County People's Hospital — Changle
- Juxian People's Hospital — Junxian
- Pingdu People's Hospital, Shandong — Pingdu
- Zouping People's Hospital — Zouping
- Huozhou Coal & Electricity Group General Hospital Co., Ltd. — Huozhou
- Huozhou People's Hospital, Huozhou Medical Group — Huozhou
- … and 547 more centers
Identifiers
NCT: NCT07007286 · 2025086