HBV, HCC
Conditions
Brief summary
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
DRUGETV,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.
DRUGETV,TDF,TAF or TMF
The study will not involve any additional interventions, nor will it interfere with any related clinical decision-making.
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year incidence of hepatocellular carcinoma (HCC) | From the start of antiviral treatment to 5 years of follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg seroclearance rate | From the start of antiviral treatment to 5 years of follow-up. |
| HBV DNA level | From the start of antiviral treatment to 5 years of follow-up. |
| HBsAg level | From the start of antiviral treatment to 5 years of follow-up. |
| HBeAg level | From the start of antiviral treatment to 5 years of follow-up. |
| HBsAg seroclearance rate | From the start of antiviral treatment to 5 years of follow-up. |
| Median time to cirrhosis | From the start of antiviral treatment to 5 years of follow-up. |
| Median time to decompensated cirrhosis | From the start of antiviral treatment to 5 years of follow-up. |
| Median time to HCC | From the start of antiviral treatment to 5 years of follow-up. |
| Overall survival (OS) | From the start of antiviral treatment to 5 years of follow-up. |
| Proportion of patients with improved or progressed liver fibrosis | From the start of antiviral treatment to 5 years of follow-up. |
Countries
China
Contacts
Primary ContactGuiqiang Wang
Outcome results
None listed