Chronic Hepatitis b
Conditions
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.
Interventions
DRUGAnti-PD-L1 antibody (ASC22)
Once two weeks, 1mg/kg, subcutaneous injection
DRUGNucleotide analogs
Once/day, 1 capsule/time, oral
DRUGPeg-IFNα
Once/week, 180μg/time, subcutaneous injection
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
Three Gorges Hospital of Chongqing University
Guizhou Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Hepatitis B surface antigen (HBsAg) level | Baseline | Serum HBsAg level |
| Serum HBsAg | 24 weeks after the treatment | Serum HBsAg level |
| Serum HBV DNA | Baseline | Serum HBV DNA level |
| Serum alanine aminotransferase (ALT) | Baseline | Serum ALT level |
Countries
China
Contacts
CONTACTDachuan Cai, MD
CONTACTMin Chen, PhD
STUDY_DIRECTORHong Ren, MM
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed