A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients
Chronic Hepatitis B, Intermediate to High Risk of HCC
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B, Hepatocellular Carcinoma, Peginterferon, Nucleos(t)ide analogue
Eligibility Criteria
Inclusion Criteria: Aged 18 to 60 years and no gender limit (including 18 and 60 years). HBsAg positive for more than 6 months. Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met. Male patient aged above 40 years. Patients with a history of cirrhosis and/or family history of liver cancer. Patients with metabolic diseases, such as diabetes, fatty liver, etc. Any liver cancer assessment model of chronic hepatitis B patients suggested that liver cancer was at intermediate to high risk. Have received Nucleos(t)ide analogue treatment for more than 24 weeks, and currently receiving Nucleos(t)ide analogue, while HBV DNA is undetectable (HBV DNA below 300 IU/mL or 1000 copies/mL). Urine and/or serum pregnancy test within 24 hours prior to the first dose must be negative for female patients of childbearing potential. Understand and voluntarily sign informed consent form. Exclusion Criteria: Patients co-infected with active hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV. Patients who have previously received interferon therapy. Alpha-fetoprotein greater than 100 ng/mL at screening, or liver imaging suggestive of liver tumor. Decompensated liver disease (Child-Pugh score ≥ 5). Pregnant or lactating women or patients planning to become pregnant or cannot to take contraception during the study. Neutrophil count < 1.5 x 109/L, platelet count < 90 x 109 cells/L, or Creatinine 1.5 times higher than the upper limit of normal. Patients with severe psychiatric history, particularly depression. History of immune-mediated disease or levels of autoimmune antibodies markedly elevated. Patients with severe diseases in major organ, such as heart, lung, kidney, brain, blood, etc., and patients with malignancies. Patients with poorly controlled diabetes, hypertension, and thyroid disease. Patients with history of severe retinopathy or other evidence of retinopathy. Patient who ever received organ transplantation, or planning to receive organ transplantation. Patients who are allergic to interferon or any of its ingredients. Other circumstances that the investigator deems inappropriate to participate in this study.
Sites / Locations
- The Public Health Clinical Center Of ChengduRecruiting
- The First Affiliated Hospital of USTC Anhui Provincial HospitalRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Ruijin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Shanghai Ninth People's Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Tongren Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- The Fifth People's Hospital Of SuzhouRecruiting
- Xiamen Hospital of Traditional Chinese MedicinRecruiting
- The Tirth Affiliated Hospital Of Xinxiang Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Combined treatment group
Monotherapy group
Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy
Nucleos (t) ide Analogue monotherapy