NCT06900166

Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg

A Prospective, Open-Label, Randomized, Controlled, Multicenter Clinical Study of Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-Negative Chronic Hepatitis B Patients with Low-Level HBsAg

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	PegIFN alfa-2b	180 μg/ 0.5 ml ,hypodermic injection once a week
DRUG	PegIFN alfa-2b and NUC	180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-03-28
• Last updated: 2025-03-28

Locations

1 site across 1 country: China