Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B — EPCP  

Hepatitis B, Chronic Clinical Trial

Official title: A Multicenter, Prospective Cohort Study: Efficacy of NA Combined With PEG-IFN-α2b Continuous Versus Pulsed Therapy for 96 Weeks in Patients With Chronic Hepatitis B.

Status Recruiting

Clinical Trial Summary

Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.

Clinical Trial Description

A large-sample, multicenter, prospective, real-world study using NAs in combination with PEG-IFN-α-2b for the treatment of CHB patients with continuous or pulsed combination therapy over a course of up to 96 weeks is proposed to compare the differences in clinical cure rates and E antigen conversion rates between groups. Multiple novel markers of hepatitis B infection, including HBV pgRNA, HBcrAg and anti-HBcAb quantification, were dynamically measured at baseline, 12, 24, 48, 72 and 96 weeks to explore the appropriate strategy for achieving clinical cure rates in CHB patients treated with NAs in combination with PEG-IFN-α-2b. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

• NCT number: NCT05922306
• Study type: Interventional
• Source: Anhui Medical University
• Contact: Yufeng Gao, MD
• Phone: 13956938032
• Email: aygyf@anmu.edu.cn
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 2023
• Completion date: December 2027