Trial | NCT02327663  Report issue

Official Title

Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    2000
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.
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.
Study Started
Dec 31
2014
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Dec 30
2014
Estimate

Drug Emtricitabine

emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24

  • Other names: Brand name：Huierding

HBeAg positive CHB group Experimental

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 Experimental

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

Criteria 

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
No Results Posted