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

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

Recruiting
18-70 years
All
Phase 4

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Overview

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Study details
    Chronic Hepatitis b

NCT07573943

The Second Affiliated Hospital of Chongqing Medical University

13 May 2026

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