Chronic hepatitis B
Conditions
Interventions
Group A:Clevudine
Group B:Adefovir Dipivoxil Tablets
Sponsors
The Third Xiangya Hospital of Central South University.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients are between 18 and 65, inclusive; 2. All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study, and female subjects may be enrolled after a negative pregnancy test; 3. HBeAg positive patient with HBV DNA >=1*10^5 copies/ml, HBeAg negative patient with HBV DNA >=1*10^4 copies/ml within 30 days of baseline; 4. Patients were documented to be HBeAg positive or negative. If HBeAg is positive, HBsAg must be positive for more than 6 months at screening; 5. Previous treatment with alpha-IFN had ended more than over 6 months prior to the screening visit; 6. Compensated hepatic function; 7. Able and willing to undergo protocol specified liver biopsy at screening and week 24. If have received biopsy (within 3 months prior to baseline), patients must have chronic hepatic inflammatory injury at screening (Knodell HAI score >= 4); investigators can obtain the specimens of biopsy sections; this item is suitable for subjects underwent liver biopsy examination; 8. ALT between 2*ULN to 10*ULN at least once within 6 months prior to screening, and ALT 1.5*ULN to 10*ULN during screening; 9. Total bilirubin 50 ml/min; 18. Able to participate and willing to give written informed consent before starting therapy; 19. Able and willing to comply with study assessments and restrictions.
Exclusion criteria
Exclusion criteria: 1. Subjects coinfected with HIV, HAV, HCV, HDV or HEV; 2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir, entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration; 3. Other chronic hepatic disease, e.g. chronic alcoholism. Wilson's disease, hemachromatosis, autoimmune hepatitis; 4. Subjects with a history of ascites, jaundice, variceal hemorrhage, hepatic encephalopathy, or other syndromes of decompensated liver disease (including portal hypertension); 5. History of lactic acidosis; 6. Concurrent use of nephrotoxic agents (e.g. aminoglycosides, amphotericin B, vancomycin, foscarnet, cisplatinum, pentamidine, cyclosporine, tacrolimus) or competitors of renal tubular excretion (e.g. sulfinpyrazone, probenecid), or hepatoxic medication (anabolic steroids, ketaconazole, itraconzaole, isoniazid, rifampin, rifabutin) within 60 days prior to screening or the expectation that the subject will receive these medications during the course of the study; 7. Poorly controlled type 1 or type 2 diabetes mellitus; 8. Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases (except asymptomatic GB stone), neurological, cardiovascular, hematologic, oncology or allergic disease. The patients with a benign tumor are excluded if judged by an investigator that the continuation of study would be interfered by benign tumor; 9. Serum albumin 1.5*ULN at screening; 11. Abnormal serum hemoglobin with clinical significance; 12. History of acute or chronic pancreatitis, serum amylase and/or lipidase > 2*ULN; 13. Using immunomodulator, including Prednisone >10 mg/day within 30 days of baseline or the expectation that the subject will receive these medications during the course of the study; 14. Any medical, severe psychiatric, occupational, or social condition (including alcohol and drug abuse) currently or within 1 year prior to screening that, in the judgment of the investigator, would interfere with, or serve as a contraindication to compliance, assessment of safety or treatment compliance, or a participant's ability to give informed consent. Severe psychiatric condition is defined as major depression or psychosis, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease, or poor compliance judged by the investigator; 15. Participation in another clinical trial or receipt of an investigational agent, for any reason, within 90 days of baseline; 16. Known allergies to nucleoside/nucleotide analogs, including Adefovir or Clevudine; 17. Resistance to Adefovir and/or Lamivudine; 18. Loss more than 400 ml blood within 60 days of baseline. 19. Evidence of drug addiction within 1 year prior to trial (including high alcohol intake: daily alcohol intake > 20 g).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Log (HBV DNA decrement) compared with the baseline at the end of week 24;;2.Histological response (subjects receive liver biopsy examination): Percentage of patients who decreased at least two scores; | — |
Countries
China
Contacts
Public ContactHonghao Zhou , Guoping Yang
Outcome results
None listed