NCT07573943

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
5mo left

Started May 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
May 2024Dec 2026

Study Start

First participant enrolled

May 21, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 7, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

April 29, 2026

Last Update Submit

July 3, 2026

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (12)

  • Serum Hepatitis B surface antigen (HBsAg) level

    Serum HBsAg level

    Baseline

  • Serum HBsAg

    Serum HBsAg level

    24 weeks after the treatment

  • Serum HBsAg

    Serum HBsAg level

    48 weeks after the treatment

  • Serum HBsAg

    Serum HBsAg level

    24 weeks after the end of treatment

  • Serum HBV DNA

    Serum HBV DNA level

    Baseline

  • Serum HBV DNA

    Serum HBV DNA level

    24 weeks after the treatment

  • Serum HBV DNA

    Serum HBV DNA level

    48 weeks after the treatment

  • Serum HBV DNA

    Serum HBV DNA level

    24 weeks after the end of treatment

  • Serum alanine aminotransferase (ALT)

    Serum ALT level

    Baseline

  • Serum alanine aminotransferase (ALT)

    Serum ALT level

    24 weeks after the treatment

  • Serum alanine aminotransferase (ALT)

    Serum ALT level

    48 weeks after the treatment

  • Serum alanine aminotransferase (ALT)

    Serum ALT level

    24 weeks after the end of treatment

Other Outcomes (9)

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

    Baseline

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

    24 weeks after the treatment

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

    48 weeks after the treatment

  • +6 more other outcomes

Study Arms (5)

Cohort 1

EXPERIMENTAL

Nucleotide 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

Drug: Anti-PD-L1 antibody (ASC22)Drug: Nucleotide analogs

Cohort 2

EXPERIMENTAL

Anti-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

Drug: Anti-PD-L1 antibody (ASC22)Drug: Nucleotide analogsDrug: Peg-IFNα

Cohort 3

EXPERIMENTAL

Peg-IFNα/Anti-PD-L1 antibody combined with nucleotide analogs Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the second 24 weeks Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for the first 24 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral

Drug: Anti-PD-L1 antibody (ASC22)Drug: Nucleotide analogsDrug: Peg-IFNα

Cohort 4

EXPERIMENTAL

Peg-IFNα combined with nucleotide analogs Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for 48 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral

Drug: Nucleotide analogsDrug: Peg-IFNα

Cohort 5

EXPERIMENTAL

Nucleotide analogs Drug: nucleotide analogs Once/day, 1 capsule/time, oral

Drug: Nucleotide analogs

Interventions

Anti-PD-L1 antibody (ASC22)DRUG

Once two weeks, 1mg/kg, subcutaneous injection

Cohort 1Cohort 2Cohort 3
Peg-IFNαDRUG

Once/week, 180μg/time, subcutaneous injection

Cohort 2Cohort 3Cohort 4
Nucleotide analogsDRUG

Once/day, 1 capsule/time, oral

Also known as: Entecavir, Tenofovir disoproxil fumarate, Tenofovir alafenamide fumarate
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavirTenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hong Ren, MM

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Central Study Contacts

Dachuan Cai, MD

CONTACT

+86 18323409779cqmucdc@cqmu.edu.cn

Min Chen, PhD

CONTACT

+86 17338600343mchen@hospital.cqmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 7, 2026

Study Start

May 21, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 7, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)