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This is a prospective study to evaluate the safety and efficacy of Sintilimab (PD-1 antibody) in sequential combination with Peg-IFNα-2b in NA-supressed CHB patients who had previously received Peg-IFNα therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-1 antibody therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 100mg/10ml/1bottle |
| |
| NAs |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBsAg loss (<0.05 IU/ml) at 24 weeks and 48 weeks | Evaluate the level of HBsAg (IU/ml) at 24 weeks and 48 weeks. | 48 weeks |
| Incidence of treatment-emergent adverse events/serious adverse events | Evaluate the treatment-emergent adverse events/serious adverse events | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks | Evaluate the level of serum HBsAg (IU/ml) at 24 weeks and 48 weeks. | 48 weeks |
| The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Fifth Medical Center, Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C015378 | nas |
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| Drug |
tablets |
|
|
| Peg-IFNα-2b | Drug | 180ug/0.5ml/1bottle |
|
The rate of HBsAb positive (>10 IU/ml) at 24 weeks and 48 weeks.
| 48 weeks |
| The concentration of HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks | Evaluate the level of serum HBcrAg (logU/mL) at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks |
| The concentration of pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks | Evaluate the level of serum pgRNA (>10 IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks | 48 weeks |
| The concentration of anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks | Evaluate the level of serum anti-HBc (IU/ml) at baseline, 12 weeks, 24 weeks and 48 weeks | 48 weeks |
| Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks | Evaluate the frequency and function of T cell, B cell, NK cell (tested by flowcytometry/fluorospot/elispot) | 48 weeks |
| 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 |