An interventional study of Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue and Nucleos(t)ide analogue in Chronic Hepatitis B and Intermediate to High Risk of HCC, sponsored by Qing XIe. Status unknown at 9 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Qing XIe · Not applicable, Interventional, and Treatment
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.
954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.
This study's planned enrollment of 267 is above the median of 100 across 692 interventional studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Qing XIe is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Patients with intermediate to high liver cancer risks. Refers to if at least one of the following items is met.
Exclusion Criteria:
Peginterferon alfa-2b Injection combined Nucleos (t) ide Analogue therapy
Drug: Peginterferon alfa-2b Injection, Nucleos (t) ide Analogue
Nucleos (t) ide Analogue monotherapy
Drug: 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.
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.
Change 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
Started Jul 2019 (actual). Primary completion is estimated for Aug 2023, 49 months after the start.
Of 43 interventional studies with no phase under Hepatitis B, Chronic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 121. This study's planned 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Qing XIe