Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Study Overview
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Brief Summary
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This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and negative Chronic hepatitis B(CHB)group.

Detailed Description
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Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB patients.

Official Title
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Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Emtricitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with body weight ≥ 33 kg and who can swallow entire emtricitabine capsle(200mg) HBsAg positive for more than 6 months HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml HBeAg positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml HBeAg positive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 Nucleoside/nucleotide naive patients Exclusion Criteria: - Diagnosed HCC with AFP and ultrasound, CT or MRI Creatine >130μmol/L or Ccr < 70mL/min Hemoglobin <100g/L Neutrophils <1.5E+9/L PLT<80E+9/L Coinfected with HAV,HEV,HCV,HDV or HIV ANA > 1:100 Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer Drug abuse or alcohol addiction Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial Underwent liver transplantation or liver transplantation in schedule Allergic to nucleoside or nucleotide analogues Pregnancy or in breastfeeding

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: naive child CHB group<br>200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks | Drug: Emtricitabine<br>* emtricitabine were given to each patients for 48 weeks<br>* Other names: Brand name：Huierding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virological response rate | HBV DNA < 500 copies/ml | week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA negativity rate | HBV DNA < 500 copies/ml | week 24 | 
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week24 and 48 | 
| biochemical response | ALT normalization | week 24 and 48 | 
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24 and 48 | 
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24 and 48 | 
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24 and 48 | 
| HBsAg loss | HBsAg loss | week 24 and 48 | 
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24 and 48 | 
| HBV genetic resistance to emtricitabine | HBV genetic resistance to emtricitabine | week 24 and 48 | 
| adverse event | type and rate of adverse events;type and rate of severe adverse event | week 24 and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B, chronic, Emtricitabine, Child