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Real-world Study on Liver Cancer Risk in Chronic Hepatitis B Patients With Family History of Liver Cancer | Clinical Trials | Clareo Health

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

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.

NCT07007286•Peking University First Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (555)

Qitaihe Infectious Disease Hospital

Heilongjiang, Heilongjiang, China

Yizheng People's Hospital

Yizheng, Jiangsu, China

Changle County People's Hospital

Changle, Shandong, China

Juxian People's Hospital

Junxian, Shandong, China

Pingdu People's Hospital, Shandong

Pingdu, Shandong, China

Zouping People's Hospital

Zouping, Shandong, China

Huozhou Coal & Electricity Group General Hospital Co., Ltd.

Huozhou, Shanxi, China

Huozhou People's Hospital, Huozhou Medical Group

Huozhou, Shanxi, China

Huozhou People's Hospital

Huozhou, Shanxi, China

Fenxi Mining Group Employees General Hospital

Jiexiu, Shanxi, China

Key Dates

Start Date

June 1, 2025

Primary Completion Date

January 1, 2032

Completion Date

December 1, 2032

Last Updated

June 5, 2025

Enrollment

1,500

ESTIMATED participants

Conditions

HBVHCC

Interventions

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

DRUG

ETV,TDF,TAF or TMF

DRUG

Contacts

Guiqiang Wang

CONTACT

01066119025 bdyyec@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

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