Chronic hepatitis B
Conditions
Interventions
Group A:Adefovir 10mg/d,p.o.qd for 104 weeks or combination with Lamivudine 10mg/d,p.o.qd at 48 weeks.Total treatment time:104 weeks
Group B:Lamivudine(LAM) 100mg/d,p.o.qd for 104 weeks or combination with Adefovir(ADV) 10mg/d,p.o.qd at 48 weeks.Total treatment time:104 weeks
Group C:Lamivudine 100mg/d,p.o.qd +Adefovir 10mg/d,p.o.qd for 104 weeks
Sponsors
Department of Infectious Diseases, Guangdong General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with CHB who were 18–60 years of age; 2. Patients who were na?ve for antiretroviral therapy with interferon a nd nucleotide analogues; 3. HBeAg-positive patients had HBV DNA levels of >=105 copies/mL, and HBeAg- negative patients had HBV DNA levels of >=104 copies/mL, and whose alanine aminotransferase (ALT) levels were >=2* the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Decompensated liver diseas; 2. Detectable antibodies against hepatitis C, D or human immunodeficiency virus; 3. Serum creatinine levels >1.5 mg? dL; 4. Ocumented or suspected HCC, pregnancy, lactation; 5. History of therapy with any anti-viral drug other than interferon-a.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virus breakthrough;Serum HBeAg level;Serum creatinine level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum HBsAg level;Poor response;Alanine aminotransferase (ALT) level; | — |
Countries
China
Contacts
Public ContactXiaoping Chen
Outcome results
None listed