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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Second Affiliated Hospital of Chongqing Medical University

About this trial

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 criteria

Qualifiers

Body mass index (BMI) of 18 to 32 kg/m²;

Serum HBsAg<100 IU/mL;

HBV DNA<20 IU/mL;

HBeAg-negative.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Anti-PD-L1 antibody (ASC22)
  • Nucleotide analogs
  • Peg-IFNα

Treatment groups

150 Participants
are divided into 5 treatment groups

Sponsors and collaborators

The Second Affiliated Hospital of Chongqing Medical University

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborator

Three Gorges Hospital of Chongqing University

Collaborator

Guizhou Provincial People's Hospital

Collaborator