RecruitingPhase 4NCT07573943

ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Enrollment

150 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis B

Summary

Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

Body mass index (BMI) of 18 to 32 kg/m\^2;
Serum HBsAg<100 IU/mL;
HBV DNA<20 IU/mL;
HBeAg-negative.

Exclusion Criteria9

A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;
Use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment;
Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;
Confirmed or suspected decompensated cirrhosis;
Malignant tumors;
Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;
Hepatitis C virus (HCV) antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);
Female in suckling period or pregnancy test (+) during screening;
Subjects who are considered by the researcher to have other factors that are not suitable for the study