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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Three Gorges Hospital of Chongqing University | OTHER |
| Guizhou Provincial People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-L1 antibody (ASC22) | Drug | Once two weeks, 1mg/kg, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dachuan Cai, MD | Contact | +86 18323409779 | cqmucdc@cqmu.edu.cn | |
| Min Chen, PhD | Contact | +86 17338600343 | mchen@hospital.cqmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hong Ren, MM | The Second Affiliated Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 2nd affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| Cohort 5 | Experimental | Nucleotide analogs Drug: nucleotide analogs Once/day, 1 capsule/time, oral |
|
| Nucleotide analogs | Drug | Once/day, 1 capsule/time, oral |
|
|
| Peg-IFNα | Drug | Once/week, 180μg/time, subcutaneous injection |
|
| 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 |
Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) |
| 24 weeks after the treatment |
| Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) | Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) | 48 weeks after the treatment |
| Other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) | Levels of other HBV markers (HBsAb, HBeAg, HBeAb, and HBcAb) | 24 weeks after the end of treatment |
| Immune response of T, B, NK and myeloid cells | Frequencies and functions of T, B, NK and myeloid cells (tested by flowcytometry/FluoroSpot/ELISPOT) | Baseline |
| Immune response of T, B, NK and myeloid cells | Frequencies and functions of T, B, NK and myeloid cells (tested by flowcytometry/FluoroSpot/ELISPOT) | 24 weeks after the treatment |
| Immune response of T, B, NK and myeloid cells | Frequencies and functions of T, B, NK and myeloid cells (tested by flowcytometry/FluoroSpot/ELISPOT) | 48 weeks after the treatment |
| Immune response of T, B, NK and myeloid cells | Frequencies and functions of T, B, NK and myeloid cells (tested by flowcytometry/FluoroSpot/ELISPOT) | 24 weeks after the end of treatment |
| Virus and host genome | Detect virus and host genome (focusing on HBV genotype, resistant mutation) using peripheral blood by sequencing | Baseline |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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