China's new cases and deaths of hepatocellular carcinoma (HCC) rank first in the world. hepatocellular carcinoma is the third most morbid, second-most mortal malignancy in China. Up to 80% of hepatocellular carcinoma patients caused by HBV infection. Antiviral therapy can significantly reduce the incidence and mortality of hepatocellular carcinoma in patients with chronic hepatitis B (CHB), hinder the progression of liver disease, and effectively control the disease. However, studies in recent years have found that long-term therapy with Nucleos(t)ide analogue (NAs) cannot completely eliminate the risk of liver cancer in patients with chronic hepatitis B. In addition, a number of retrospective studies at home and abroad have shown that compared with long-term oral NAs, peginterferon can significantly reduce the risk of hepatocellular carcinoma in patients with chronic hepatitis B. However, there is limit prospective studies. This multicenter, randomized, open-label, controlled trial study is aim to evaluate the pegylated interferon alfa-2b injection in comparing to NAs in reducing the incidence of hepatocellular carcinoma, to provide evidences for new management and treatment strategy options for improving clinical outcomes for the chronic hepatitis B patients. About 267 chronic hepatitis patients with intermediate to high risk of liver cancer who are now receiving nucleoside therapy will be enrolled. Subjects will be randomized into the peginterferon combined NAs group and the NAs monotherapy group at a ratio of 2:1. Level of HBsAg, proportion of patients with HBsAg clearance and seroconversion, incidence of liver cirrhosis and hepatocellular carcinoma will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
267
1.Peginterferon alfa-2b injection: 180μg, subcutaneously inject, once a week, from week 1 to Week 48. 2, NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated. NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
NAs: Dose please follow the approved dosage, once daily, from the first day until when discontinuation is indicated. NAs Discontinuation Criteria: A total course of treatment is recommended for at least 4 years, and discontinuation may be considered if HBV DNA is below the lower limit of detection, Alanine aminotransferase renormalization, and HBeAg serological conversion, and remain unchanged (test every 6 months) during a consolidation therapy for at least 3 years. However, a prolonged course of treatment may reduce relapse.
The Public Health Clinical Center Of Chengdu
Chengdu, China
RECRUITINGThe First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, China
RECRUITINGRuijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGShanghai Ninth People's Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGTongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGThe Fifth People's Hospital Of Suzhou
Suzhou, China
RECRUITINGXiamen Hospital of Traditional Chinese Medicin
Xiamen, China
RECRUITINGThe Tirth Affiliated Hospital Of Xinxiang Medical University
Xinxiang, China
RECRUITINGChange of HBsAg level compared to baseline
Time frame: week 48 of treatment
Proportion of patients with HBsAg clearance
Time frame: At week 48 of treatment and 5 years of follow up
Proportion of patients with HBsAg seroconversion
Time frame: At week 48 of treatment and 5 years of follow up
Proportion of patients with change of liver stiffness measurement (LSM)
Time frame: At week 48 of treatment and 5 years of follow up
Incidence of liver cirrhosis and hepatocellular carcinoma
Time frame: At week 48 of treatment and 5 years of follow up
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