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

Sponsor
Peking University First Hospital
Study ID
NCT07007286
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jun 5, 2025
Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Jan 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: PEG IFNα-2b Group
  • Arm: Nucleos(t)ide Monotherapy Group

Primary Outcome Measure

5-year incidence of hepatocellular carcinoma (HCC) [ Time Frame: From the start of antiviral treatment to 5 years of follow-up. ]

Central Contacts

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