ASC22 plus pegylated interferon alfa to try to achieve a functional cure for chronic hepatitis B

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

This trial tests whether adding ASC22 (an anti–PD‑L1 antibody) to pegylated interferon alfa with background antiviral pills can help adults with HBeAg‑negative chronic hepatitis B and very low viral markers reach a functional cure.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT07573943 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional trial in China combines an anti‑PD‑L1 monoclonal antibody (ASC22) with pegylated interferon alfa and background nucleotide analog therapy in adults with chronic hepatitis B who are HBeAg‑negative and have low HBsAg and undetectable HBV DNA. The protocol enrolls patients with HBsAg <100 IU/mL, HBV DNA <20 IU/mL and BMI 18–32 kg/m2, while excluding those with decompensated cirrhosis, malignancy, significant comorbidities, active infections, or recent immunosuppressive therapy. The primary goals are to characterize safety and to see if this combination can raise the overall functional cure rate to more than 50% without preselecting advantaged subgroups. The trial is sponsored by The Second Affiliated Hospital of Chongqing Medical University with participating regional hospitals.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic hepatitis B who are HBeAg‑negative, have very low HBsAg (<100 IU/mL) and undetectable HBV DNA (<20 IU/mL), and meet BMI and other screening criteria.

Not a fit: Patients with decompensated cirrhosis, active serious systemic disease or infections, recent immunosuppressant or cytotoxic therapy, certain co‑infections (HCV, HIV, syphilis), malignancy, or higher HBsAg/HBV DNA levels are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this combination could substantially increase functional cure rates for eligible chronic hepatitis B patients and potentially allow some people to stop long‑term antiviral therapy.

How similar studies have performed: Similar approaches combining immune checkpoint blockade with interferon or antivirals have shown promising early signals in small studies but have not yet produced widely replicated high cure rates, so the strategy remains experimental.

Eligibility criteria

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

Where this trial is running

Chongqing, Chongqing Municipality

• The 2nd affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dachuan Cai, MD

Conditions Chronic Hepatitis b