Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Phase 4

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Emtricitabine

• Registration Number: NCT02327676
• Lead Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Brief Summary

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

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.

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30
• Study Start: 2015-01
• Primary Completion: 2015-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
naive child CHB group	Emtricitabine	200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks

Primary Outcome Measures

Name	Time	Method
virological response rate	week 48	HBV DNA \< 500 copies/ml

Secondary Outcome Measures

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