Emtricitabine for Naive Child 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

NCT02327676

FTC-01-child patients

Details and patient eligibility

About

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.

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 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

naive child CHB group

Experimental group

Description:

200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks

Treatment:

Drug: Emtricitabine