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This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b combined with NAs | Drug | Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver histological score from baseline | 24 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hepatocellular carcinoma (HCC) | Week 48 | |
| Incidence of hepatic decompensation events | Week 48 | |
| Change in liver stiffness measurement (LSM) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenqi Huang | Contact | 18965179823 | huangwenqi@haxm.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenqi Huang | Xiamen Humanity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | China |
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| ID | Term |
|---|---|
| C015378 | nas |
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| NAs | Drug | Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status. |
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Evaluation is performed using liver imaging data such as liver MRI and histopathological data. |
| Week 48,24 weeks after the end of treatment |
| Change in AST-to-Platelet Ratio Index (APRI) from baseline | Week 48,24 weeks after the end of treatment |
| Change in Fibrosis-4 Index (FIB-4) from baseline | Week 48,24 weeks after the end of treatment |
| HBsAg loss rate | Week 48,24 weeks after the end of treatment |
| Seroconversion rate | Week 48,24 weeks after the end of treatment |
| HBeAg loss rate | Week 48,24 weeks after the end of treatment |
| HBV DNA undetectability rate | Week 48,24 weeks after the end of treatment |
| HBV RNA undetectability rate | Week 48,24 weeks after the end of treatment |
| HBV RNA decline rate | Week 48,24 weeks after the end of treatment |
| Zhongshan Hospital Affiliated to Xiamen University | Xiamen | China |
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