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There are nearly 2 million HBsAg-positive children who are in urgent need of professional diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood liver disease. After infected with HBV virus, some children will develop disease progression, and some even develop cirrhosis and/or liver cancer. In pediatric liver cancer cases, up to 34% ~ 95% are caused by HBV infection.
Although two major classes of drugs have been approved for the treatment of chronic hepatitis B in adults, and there are multiple guidelines worldwide for the management of HBV infection in adults, there is lack of guidelines specifically for the management of children with HBV infection. In addition, the treatment of chronic hepatitis B in children faced great difficulties due to the lack of evidence-based medical evidence for antiviral treatment of chronic hepatitis B in children and fewer drugs approved for anti-HBV treatment in children. The timing of treatment, medications, and clinical management strategies are all controversial.
This study ( Sprout project),is a multicenter, prospective, cohort study in China, aiming to explore and optimize the antiviral treatment regimen for children with HBV infection, to provide evidence-based medical for antiviral treatment, and to provide basis evidence for the standardized management of children infection with HBV in China. The study is expected to enroll 1900 pediatric patients with HBV infection, and patient will received one of the three following treatment Strategies: nucleoside monotherapy, peginterferon α- combined with nucleoside therapy, or peginterferon α-pulse therapy combined with nucleoside therapy, according to their illness state and desire, and the safety and efficacy will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment-naïve children with hepatitis B | Experimental |
| |
| previously treated children with hepatitis B | Experimental |
| |
| chronic HBV carrying children with normal ALT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2b combined and ETV | Drug | Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300.
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate. | Defined as the proportion of child patients with HBsAg < 0.05 IU / mL (or below the lower detection limit) 24 weeks after completing treatment, HBeAg negative, HBV DNA undetectable, and normalization of liver biochemical indexes (ALT and AST). | 24 weeks after completing treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with HBV-DNA negative in those with HBV-DNA positive at baseline. | Defined as HBV-DNA below the lower detection limit, or< 20 IU/mL. | 24 weeks after treatment completion |
| HBeAg seroconversion rate in HBeAg positive children. |
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Inclusion Criteria:
1.Inclusion criteria for treatment-naïve children with hepatitis B:
2.Inclusion criteria for NA-treated children with hepatitis B:
3.Inclusion criteria for chronic HBV carrying children with normal ALT:
Exclusion Criteria:
Co-infected with HAV, HCV, HDV, HEV or HIV.
Patients with contraindications to peginterferon alfa-2b, including but not limit to :
Child patient with severe renal dysfunction, e.g. creatinine > 1.5 ULN.
Child patient who in the opinion of the investigator is unsuitable for enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Wang | Contact | +8613682662543 | kaixin919@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing He | Shenzhen Third People's Hospital | Principal Investigator |
| Hongfei Zhang | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Fang Wang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Third People Hospital | Recruiting | Shenzhen | China |
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| ID | Term |
|---|---|
| C413685 | entecavir |
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|
Defined as HBeAg negative and anti-HBe positive.
| 24 weeks after treatment completion. |
| HBsAg seroconversion rate. | Defined as HBsAg < 0.05 IU/mL and anti-HBe positive. | 24 weeks after treatment completion. |
| ALT normalization rate. | 48 weeks and 96 weeks after starting treatment |
| Decrease of HBV-DNA compared to baseline. | 24 weeks after treatment completion. |
| Decrease of HBeAg compared to baseline. | 24 weeks after treatment completion. |
| Decrease of HBsAg compared to baseline. | 24 weeks after treatment completion. |
| The incidence of adverse reactions. | Including fever, influenza-like symptoms, decreased hemogram, jaundice ALT> 400U/L, abnormal renal function, abnormal thyroid function, abnormal blood phosphorus and blood calcium during treatment (lower or higher than the normal value). | 24weeks ,48 weeks and 96 weeks after starting treatment |
| The effects on height | 24weeks ,48 weeks and 96 weeks after starting treatment |
| The effects on weight | 24weeks ,48 weeks and 96 weeks after starting treatment |
| The effects on bone age. | 24weeks ,48 weeks and 96 weeks after starting treatment |
| Shenzhen Third People's Hospital |
| Study Chair |