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The purpose of this study is to provide theoretical and real world evidence for the optimization of antiviral treatment by IFN combined with Nucleosides analog in HBeAg positive chronic hepatitis B patients aged 1-16 years,so that the functional cure could be achieved in the greatest extent in pediatric patients
This research is a national multicenter, randomized, prospective study. The planned sample size is 200 subjects in 1-16 years pediatric patients with HBeAg positive Chronic Hepatitis B (CHB). These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups. Regularly Blood cell count, biochemical test, hepatitis B viral markers test, and lymphocyte subsets test were exerted. To compare the curative effect of group A and group B, The primary monitoring indicator is HBsAg clearance rate, and the secondary monitoring indicator is hepatitis B virus (HBV) DNA clearance,HBeAg seroconversion in these patients,. So that we can make the optimal antiviral treatment strategy for 1-16-year-old children with CHB,and try to find out the possible influencing factors of function cure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAs+IFN-α | Experimental | NAs+IFN-α/ 96w |
|
| NAs+(IFN-α+ NAs ) | Other | NAs/48w+(IFN-α+ NAs)/96w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAs+IFN-α | Drug | NAs+IFN-α:(NAs +IFN)/96 weeks:NAs(when the CHB patients<2years old, the drug is LAM)combined with IFN-α(when the CHB patients<3years old, the drug is IFN-α)for 96 weeks。 NAs+(NAs+IFN-α) :NAs/48weeks+(NAs+ IFN)/96 weeks:NAs(when the CHB patients<2years old, the drug is LAM)for 48 weeks ,then combined with IFN-α(when the CHB patients<3years old, the drug is IFN-α)for 96weeks。 Response guided treatment(RGT) by HBsAg quantification: The course of interferon alpha was 24 weeks after HBsAg and HBeAg turned negative up to 96 weeks, and NAs was discontinued 12 months after HBsAg serological conversion. |
| Measure | Description | Time Frame |
|---|---|---|
| The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks | The rates of HBsAg serological disappearance / conversion in CHB patients at 48 weeks | 48 weeks |
| The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks | The rates of HBsAg serological disappearance / conversion in CHB patients at 96 weeks | 96 weeks |
| The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks | The rates of HBsAg serological disappearance / conversion in CHB patients at 144 weeks | 144 weeks |
| The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks | The rates of HBsAg serological disappearance / conversion in CHB patients at 168 weeks | 168 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of HBeAg clearance / seroconversion | The rate of HBeAg clearance / seroconversion in patients with CHB | 168 weeks |
| HBV DNA negative conversion rate | HBV DNA negative conversion rate in patients with CHB |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related side effect and safety events as assessed by GSI | Side effect and safety events include adverse events, adverse drug reactions etc. during the treatment | 168 weeks |
| Average duration of HBeAg seroconversion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Zhang, Doctor | Contact | 13911517721 | 010-63879847 | gcmw2001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Zhang, Dcotor | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Min Zhang | 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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These subjects will be randomized (1:1) to group A(treated with NAs + IFN for 96 weeks) and group B(treated with NAs for 48 weeks, then NAs combined with IFN for 96 weeks).Meanwhile, 1-6 years and 7-16 years patients should be distributed by 1:1 ratio by random method in both groups.
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|
| 168 weeks |
| ALT(Alanine aminotransferase) recovery rate | ALT recovery rate in patients with CHB | 168 weeks |
Average duration of HBeAg seroconversion during treatment
| 168 weeks |
| Average duration of disappearance of HBsAg | Average duration of disappearance of HBsAg during treatment | 168 weeks |
| Assessed the changes of liver stiffness measure by FibroScan after antiviral therapy | Comparison the changes of liver stiffness before and after antiviral treatment (evaluated by FibroScan) | 168 weeks |
| Rate of relapse in patients after stop of antiviral therapy of NAs | Rate of relapse in patients after stop of antiviral therapy of NAs | 168 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 |