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To date, antiviral treatment is not recommended for chronic hepatitis B patients with a normal ALT level and low viremia. The strategy is to closely monitor the patients. However, evidence suggests that these group are at risk of gradual disease progression and development of hepatocellular carcinoma. Peginterferon eliminates the hepatitis B virus through immune regulation and induction of antiviral protein expression. For patients with low viral load, the clinical cure rate is potentially promising. In this study, we aim to investigate the efficacy and safety of peginterferon alpha-2b therapy in selected chronic hepatitis B patients with normal ALT level and low viremia. It is expected to obtain a satisfactory curative effect. Peginterferon is a marketed drug available in Chinese clinics with indications of anti-hepatitis B virus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monotherapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. |
|
| continuous combination therapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 48 consecutive weeks, plus continuous oral NA. Patients will stop the treatment whenever HBsAg is eliminated, and those without HBsAg elimination after 48 dosages will enter the group of best treatment. The patients will be followed up for another 24 weeks after treatment. |
|
| pulse combination therapy group | Experimental | Peginterferon alpha-2b injection is given subcutaneously at a dosage of 180μg/w for 8 consecutive weeks and cessation for 4 weeks,plus continuous oral NA. Patients will discontinue the treatment at any time if they are recovery, and those without HBsAg elimination after 48 dosages will enter the group of best treatment.The patients will be followed up for another 24 weeks after treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alpha-2b | Drug | 180μg/w |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with undetectable HBV DNA | week 24 | |
| HBsAg clearance rate | week 48 | |
| HBsAg conversion rate | week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with undetectable HBV DNA | week 24 and week 48 | |
| The HBsAg level | week 24 and week 48 | |
| The HBV pgRNA level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongliang Li, Professor | Contact | 008613665052006 | dongliangli93@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital, Xiamen Univ | Recruiting | Fuzhou | Fujian | 350025 | China |
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| Nucleotide Analog | Drug | Etecavir 0.5mg qd or Tenofovir 300mg qd |
|
| pulse peginterferon alpha-2b | Drug | 180μg/w for 8 consecutive weeks and cessation for 4 weeks |
|
| week 24 and week 48 |
| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D009711 | Nucleotides |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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