Emtricitabine for Naive 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 chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg 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. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.

Official Title
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Emtricitabine for Naive 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: HBsAg positive for more than 6 months HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml HBeAg postive 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 postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4 nucleoside/nucleotide naive paitents 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 cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer Drug abuse or alcohal 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 Preganency or in breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBeAg positive CHB group<br>1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined | Drug: Emtricitabine<br>* emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24<br>* Other names: Brand name：Huierding;|
| Experimental: HBeAg negativie CHB group<br>1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined | Drug: Emtricitabine<br>* emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24<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 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week24, 48, 72 and 96 | 
| HBV DNA negativity rate | HBV DNA < 500 copies/ml | week 24, 48 and 72 | 
| biochemical response | ALT normalization | week 24,48,72 and 96 | 
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24,48,72 and 96 | 
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24,48,72 and 96 | 
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24,48,72 and 96 | 
| HBsAg loss | HBsAg loss in both group | week 24,48,72 and 96 | 
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24,48,72 and 96 | 
| adverse event | type and rate of adverse events;type and rate of severe adverse event; | week 24,48,72 and 96 | 
| HBV genetic resistance to emtricitabine and adefovir | HBV genetic resistance to emtricitabine and adefovir | week 24,48,72 and 96 | 

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