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

ConditionChronic Hepatitis b
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
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

This trial does not accept healthy volunteers

Qualifiers

Sign the informed consent form before inclusion and be able to complete the study according to the study requirements

From inclusion to 30 days after the last administration of the study drug, male subjects or female subjects of childbearing age are willing to voluntarily take effective contraceptive measures

18-60 years old. The weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg/m2

Serum HBsAg<100 IU/mL

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 inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment

Systematical 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anti-PD-L1 antibody (ASC22)

    Drug

    Once two weeks, 1mg/kg, subcutaneous injection

  • Nucleotide analogs

    Drug

    Once/day, 1 capsule/time, oral

  • Peg-IFNα

    Drug

    Once/week, 180μg/time, subcutaneous injection

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 3 interventions
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum Hepatitis B surface antigen (HBsAg) level

Serum HBsAg level

Time frame
Baseline
2

Serum HBsAg

Serum HBsAg level

Time frame
24 weeks after the treatment
3

Serum HBsAg

Serum HBsAg level

Time frame
48 weeks after the treatment
4

Serum HBsAg

Serum HBsAg level

Time frame
24 weeks after the end of treatment

Secondary outcomes

Other outcomes

1

Other HBV markers: Hepatitis B surface antibody (HBsAb), Hepatitis B e antigen (HBeAg), Hepatitis B e antibody (HBeAb), and Hepatitis B core antibody (HBcAb).

Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Time frame
Baseline
2

Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Time frame
24 weeks after the treatment
3

Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Time frame
48 weeks after the treatment
4

Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb)

Time frame
24 weeks after the end of treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Affiliated Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov
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