Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B, chronic, Emtricitabine, Adefovir dipivixil, HBeAg
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.
Interventions
DRUGEmtricitabine
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
Sponsors
Beijing Ditan Hospital
Hebei Medical University Pharmaceutical Factory
National Health and Family Planning Commission, P.R.China
Asian-Pacific Alliance of Liver Disease, Beijing
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| virological response rate | week 96 | HBV DNA \< 500 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA negativity rate | week 24, 48 and 72 | HBV DNA \< 500 copies/ml |
| 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 seroconversion | week 24,48,72 and 96 | HBeAg seroconversion in HBeAg positive group |
| HBV DNA decrease level | week24, 48, 72 and 96 | HBV DNA decrease compared with baseline（log10 copies/ml） |
| HBsAg loss | week 24,48,72 and 96 | HBsAg loss in both group |
| HBsAg seroconversion | week 24,48,72 and 96 | HBsAg loss and anti-HBs positive |
| 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 |
| HBeAg reversion | week 24,48,72 and 96 | HBeAg positive in Baseline HBeAg negativie group patients |
Contacts
Primary ContactJun Cheng, M.D.
Backup ContactSong Yang, M.D.
Outcome results
None listed