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RECRUITING
NCT05922306
EARLY_PHASE1

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

Sponsor: Anhui Medical University

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

1084

Start Date

2023-07

Completion Date

2027-12

Last Updated

2023-06-28

Healthy Volunteers

No

Interventions

DRUG

PEGylated recombinant human interferon alpha-2b injection

Continuous combination therapy: pegylated interferon alpha-2b 180µg, subcutaneously once a week for 96 weeks, combined with NAs throughout the treatment period.

DRUG

PEGylated recombinant human interferon alpha-2b injection

Pulsed combination therapy: pegylated interferon alpha-2b 180µg once weekly by subcutaneous injection for 8 weeks with 4 weeks off for a total treatment duration of 96 weeks, combined with NAs throughout the treatment period.

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China