Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
- Registration Number
- NCT02327663
- Lead Sponsor
- Asian-Pacific Alliance of Liver Disease, Beijing
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HBeAg positive CHB group Emtricitabine 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 HBeAg negativie CHB group Emtricitabine 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
- Primary Outcome Measures
Name Time Method virological response rate week 96 HBV DNA \< 500 copies/ml
- Secondary Outcome Measures
Name Time Method biochemical response week 24,48,72 and 96 ALT normalization
HBeAg loss week 24,48,72 and 96 HBeAg loss in HBeAg positive group
HBeAg reversion week 24,48,72 and 96 HBeAg positive in Baseline HBeAg negativie group patients
HBV DNA decrease level week24, 48, 72 and 96 HBV DNA decrease compared with baseline（log10 copies/ml）
HBV DNA negativity rate week 24, 48 and 72 HBV DNA \< 500 copies/ml
HBsAg loss week 24,48,72 and 96 HBsAg loss in both group
HBeAg seroconversion week 24,48,72 and 96 HBeAg seroconversion in HBeAg positive group
adverse event week 24,48,72 and 96 type and rate of adverse events;type and rate of severe adverse event;
HBV genetic resistance to emtricitabine and adefovir week 24,48,72 and 96 HBV genetic resistance to emtricitabine and adefovir
HBsAg seroconversion week 24,48,72 and 96 HBsAg loss and anti-HBs positive