Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B, chronic, Emtricitabine, Child
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.
Interventions
DRUGEmtricitabine
emtricitabine were given to each patients for 48 weeks
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
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| virological response rate | week 48 | HBV DNA \< 500 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA decrease level | week24 and 48 | HBV DNA decrease compared with baseline（log10 copies/ml） |
| biochemical response | week 24 and 48 | ALT normalization |
| HBeAg loss | week 24 and 48 | HBeAg loss in HBeAg positive group |
| HBeAg seroconversion | week 24 and 48 | HBeAg seroconversion in HBeAg positive group |
| HBV DNA negativity rate | week 24 | HBV DNA \< 500 copies/ml |
| HBsAg loss | week 24 and 48 | HBsAg loss |
| HBsAg seroconversion | week 24 and 48 | HBsAg loss and anti-HBs positive |
| HBV genetic resistance to emtricitabine | week 24 and 48 | HBV genetic resistance to emtricitabine |
| adverse event | week 24 and 48 | type and rate of adverse events;type and rate of severe adverse event |
| HBeAg reversion | week 24 and 48 | HBeAg positive in Baseline HBeAg negativie group patients |
Contacts
Primary ContactJun Cheng, M.D.
Backup ContactSong Yang, M.D.
Outcome results
None listed