RecruitingPhase 4

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

China150 participantsStarted 2024-05-21

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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;

What they're measuring

Serum Hepatitis B surface antigen (HBsAg) level

Timeframe: Baseline

Serum HBsAg

Timeframe: 24 weeks after the treatment

Serum HBsAg

Timeframe: 48 weeks after the treatment

Serum HBsAg

Timeframe: 24 weeks after the end of treatment

Serum HBV DNA

Timeframe: Baseline

Serum HBV DNA

Timeframe: 24 weeks after the treatment

Serum HBV DNA

Timeframe: 48 weeks after the treatment

Serum HBV DNA

Timeframe: 24 weeks after the end of treatment

Serum alanine aminotransferase (ALT)

Trial details

NCT IDNCT07573943

SponsorThe Second Affiliated Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Dachuan Cai, MD

+86 18323409779 cqmucdc@cqmu.edu.cn

View on ClinicalTrials.gov More Chronic Hepatitis b trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

✕. 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;

What they're measuring

Serum Hepatitis B surface antigen (HBsAg) level

Timeframe: Baseline

Serum HBsAg

Timeframe: 24 weeks after the treatment

Serum HBsAg

Timeframe: 48 weeks after the treatment

Serum HBsAg

Timeframe: 24 weeks after the end of treatment

Serum HBV DNA

Timeframe: Baseline

Serum HBV DNA

Timeframe: 24 weeks after the treatment

Serum HBV DNA

Timeframe: 48 weeks after the treatment

Serum HBV DNA

Timeframe: 24 weeks after the end of treatment

Serum alanine aminotransferase (ALT)