Fibrosis, Hepatitis B, Chronic
Conditions
Keywords
Hepatitis B virus, Cirrhosis, Emtricitabine, Adefovir dipivoxil
Brief summary
This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
Interventions
DRUGEmtricitabine plus adefovir dipivoxil
emtricitabine plus adefovir dipivoxil were given to each patients for 96 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
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dignosed cirrhosis patients * HBsAg positive for more than 6 months * HBV DNA detectable * 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 * 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 96 | HBV DNA \< 500 copies/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA decrease level | week24, 48, 72 and 96 | HBV DNA decrease compared with baseline（log10 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 |
| HBeAg reversion | week 24,48,72 and 96 | HBeAg positive in Baseline HBeAg negativie group patients |
| HBV DNA negativity rate | week 24, 48 and 72 | HBV DNA \< 500 copies/ml |
| HBsAg seroconversion | week 24,48,72 and 96 | HBsAg loss and anti-HBs positive |
| HBV genetic resistance to emtricitabine and adefovir | week 24,48,72 and 96 | HBV genetic resistance to emtricitabine and adefovir |
| adverse event | week 24,48,72 and 96 | type and rate of adverse events;type and rate of severe adverse event |
| incidence of HCC | week 24,48,72 and 96 | incidence of HCC in both groups |
| change of MELD score and Child-Pugh score | week 24,48,72 and 96 | change of MELD score and Child-Pugh score in both groups |
| HBsAg loss | week 24,48,72 and 96 | HBsAg loss in both group |
Contacts
Primary ContactJun Cheng, M.D.
Backup ContactSong Yang, M.D.
Outcome results
None listed