RecruitingNot ApplicableNCT05671315

A Prospective Study to Evaluate Peginterferon in Reducing the Incidence of HCC in CHB Patients

A Prospective, Randomized, Open-label, Multicenter Study to Evaluate the Peginterferon, Comparing to Nucleos(t)Ide Analogues, in Reducing the Incidence of HCC in Chronic Hepatitis B Patients With Intermediate to High Liver Cancer Risks

Sponsor

Qing XIe

Enrollment

267 participants

Start Date

Jul 3, 2019

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B Intermediate to High Risk of HCC

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether peginterferon (a type of immune-stimulating injection) can reduce the risk of developing liver cancer (hepatocellular carcinoma, or HCC) in people with chronic hepatitis B (HBV) who are at intermediate to high risk. Chronic hepatitis B is a viral liver infection that can lead to cirrhosis and liver cancer. **You may be eligible if...** - You are 18–60 years old - You have had hepatitis B surface antigen (HBsAg) positive results for more than 6 months - You are at intermediate to high risk of liver cancer (e.g., male over 40, history of liver scarring, family history of liver cancer, or diabetes) - You are already on nucleoside/nucleotide antiviral treatment for hepatitis B **You may NOT be eligible if...** - You already have liver cancer or cirrhosis that is decompensated (severe liver failure) - You have other serious liver diseases (such as hepatitis C or autoimmune hepatitis) - You have poorly controlled diabetes or thyroid disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPeginterferon alfa-2b Injection, Nucleos (t) ide Analogue

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.

DRUGNucleos(t)ide analogue

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.