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NOT YET RECRUITING
NCT07809165
NA

Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B

Sponsor: Beijing 302 Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.

Official title: Safety and Efficacy of Sequential Treatment With a PD-1 Antibody and Pegylated Interferon-α in Nucleos(t)Ide Analogue-Suppressed Patients With Chronic Hepatitis B

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09

Completion Date

2029-09

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab will be administered intravenously at a dose of 1.0 mg/kg at Weeks 0, 6, 12, and 18, for a total of four doses.

DRUG

Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 12 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol. When sintilimab and Peg-IFNα are scheduled during the same treatment period, administration of the two drugs will be separated by at least 72 hours.

DRUG

Nucleos(t)ide Analogues

Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.

DRUG

Pegylated Interferon-α 2b

Peg-IFNα will be administered subcutaneously once weekly from Week 0 through Week 48. Dose: 135 μg or 180 μg, according to the study protocol.

DRUG

Nucleos(t)ide Analogues

Background nucleos(t)ide analogue therapy with entecavir, tenofovir disoproxil fumarate, or tenofovir alafenamide will be continued throughout the study.

Locations (4)

Shandong Public Health Clinical Center

Jinan, China

The Third People's Hospital of Taiyuan

Taiyuan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China