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This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PD-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peg-IFNα group | Active Comparator | 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs |
|
| PD-1 antibody group | Active Comparator | 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks NAs |
|
| PD-1 antibody combined Peg-IFNα group | Experimental | 1.5 mg/kg Sintilimab intravenous injection once per 3 weeks for 24 weeks 180 ug Peg-IFNα-2b subcutaneous injection once/week for 48 weeks NAs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 100mg/10ml/1bottle |
| |
| Peg-IFNα-2b |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBsAg loss at 24 weeks and 48 weeks. | Evaluate the level of HBsAg 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 at 24 weeks and 48 weeks. | 48 weeks |
| The rate of HBsAb positive at 24 weeks and 48 weeks. | Evaluate the level of serum HBsAb 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 | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40976664 | Derived | Wang H, Li X, Lu J, Zhang X, Dang S, Li Y, He Y, Guo Y, Wang J, Maimaitijiang W, Zheng S, Ren S, Cao H, Zhang W, Zhang X, Ma H, Wang FS, Fu J. Safety and efficacy of PD-1 antibody combined with pegylated interferon alpha for functional cure in nucleos(t)ide analogues-suppressed chronic hepatitis B patients: protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Sep 21;15(9):e105710. doi: 10.1136/bmjopen-2025-105710. |
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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 |
180ug/0.5ml/1bottle |
|
| NAs | Drug | tablets |
|
|
| 48 weeks |
| The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. | Evaluate the level of serum HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks |
| The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. | Evaluate the level of serum pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks. | 48 weeks |
| The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks. | Evaluate the level of serum anti-HBc 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 |