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Chronic Hepatitis bPhase 4NCT07573943

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

A Phase 4 study testing Anti-PD-L1 antibody (ASC22), Nucleotide analogs and Peg-IFNα in people with Chronic Hepatitis b, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Hepatitis b
What is being tested?
Anti-PD-L1 antibody (ASC22), Nucleotide analogs and Peg-IFNα
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
21 May 2024to 31 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
  • HBV DNA<20 IU/mL
  • HBeAg-negative

Who cannot join

  • 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
  • Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers)
  • Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive liver fibrosis
Show all 19Show fewer
  • Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug/L or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years before enrollment (except that the malignant tumors have been completely relieved after treatment and patients have not received additional medical or surgical intervention within 3 years before screening)
  • A history of pathological fracture or osteoporosis
  • Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms (such as nausea, vomiting, or diarrhea) >2 grades
  • Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems
  • Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period
  • Blood donation/loss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation/loss ≥ 200 mL within 1 month before enrollment
  • Platelet count<90 × 10^9/L, white blood cell count<3.0 × 10^9/L, neutrophil count<1.3 × 10^9/L, total serum bilirubin>2 × ULN, albumin<30 g/L, creatinine clearance ≤ 60 mL/min (calculated by CKD-EPI formula), or international normalized ratio of prothrombin time (INR)>1.5 (unless receiving stable anticoagulant therapy)
  • HCV antibody (+), HIV antigen/antibody (+), or treponema pallidum antibody (+) and RPR test (+)
  • A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram)
  • A history of drug dependence or drug abuse within 1 year before enrollment
  • Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment
  • Female in suckling period or pregnancy test (+) during screening
  • Subjects who are considered by the researcher to have other factors that are not suitable for the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dachuan Cai, MD contact

+86 18323409779

cqmucdc@cqmu.edu.cn

Min Chen, PhD contact

+86 17338600343

mchen@hospital.cqmu.edu.cn

China1 site, 1 recruiting

  • The 2nd affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    HONG REN, +8613983888786, renhong0531@vip.sina.com

    Dachuan Cai, +8618323409779, cqmucdc@cqmu.edu.cn

    Recruiting

Other trials in China

About this study

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.

Being tested
Anti-PD-L1 antibody (ASC22), Nucleotide analogs, Peg-IFNα
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-PD-L1 antibody (ASC22)Drug

    Once two weeks, 1mg/kg, subcutaneous injection

  • Nucleotide analogsDrug

    Also called Entecavir, Tenofovir disoproxil fumarate, Tenofovir alafenamide fumarate

    Once/day, 1 capsule/time, oral

  • Peg-IFNαDrug

    Once/week, 180μg/time, subcutaneous injection

Study groups in NCT07573943
Study groupRoleWhat they receive
Cohort 1ExperimentalNucleotide analogs combined with anti-PD-L1 antibody (ASC22). Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the first 24 weeks Drug: Nucleotide analogs Once/day, 1 capsule/time, oral
Receives: Drug: Anti-PD-L1 antibody (ASC22); Drug: Nucleotide analogs
Cohort 2ExperimentalAnti-PD-L1 antibody/pegylated interferon alfa (Peg-IFNα) combined with nucleotide analogs Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the first 24 weeks Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for the second 24 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral
Receives: Drug: Anti-PD-L1 antibody (ASC22); Drug: Nucleotide analogs; Drug: Peg-IFNα
Cohort 3ExperimentalNucleotide analogs Drug: nucleotide analogs Once/day, 1 capsule/time, oral
Receives: Drug: Nucleotide analogs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Hepatitis B surface antigen (HBsAg) level

    Serum HBsAg level

    Measured: Baseline

  2. Serum HBsAg

    Serum HBsAg level

    Measured: 24 weeks after the treatment

  3. Serum HBsAg

    Serum HBsAg level

    Measured: 48 weeks after the treatment

  4. Serum HBsAg

    Serum HBsAg level

    Measured: 24 weeks after the end of treatment

  5. Serum HBV DNA

    Serum HBV DNA level

    Measured: Baseline

  6. Serum HBV DNA

    Serum HBV DNA level

    Measured: 24 weeks after the treatment

  7. Serum HBV DNA

    Serum HBV DNA level

    Measured: 48 weeks after the treatment

  8. Serum HBV DNA

    Serum HBV DNA level

    Measured: 24 weeks after the end of treatment

  9. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: Baseline

  10. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 24 weeks after the treatment

  11. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 48 weeks after the treatment

  12. Serum alanine aminotransferase (ALT)

    Serum ALT level

    Measured: 24 weeks after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start21 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573943
Sponsor's protocol ID
20231223
Status last verified
Apr 2026
First submitted
29 Apr 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anti-PD-L1 antibody (ASC22), Nucleotide analogs and Peg-IFNα in people with Chronic Hepatitis b, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dachuan Cai, MD (+86 18323409779, cqmucdc@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Hepatitis B surface antigen (HBsAg) level (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07573943.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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