Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Asian-Pacific Alliance of Liver Disease, Beijing

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Emtricitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02327663

FTC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

HBeAg positive CHB group

Experimental group

Description:

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

Treatment:

Drug: Emtricitabine

HBeAg negativie CHB group

Experimental group

Description:

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

Treatment:

Drug: Emtricitabine