Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT
Hepatitis B
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B
Eligibility Criteria
Inclusion Criteria: older than 18 years HBsAg+ at screening and for at least 6 months prior to study entry HBeAg+ HBV DNA greater than 6 log10 copies/mL Platelet count greater than 50,000 platelets/mm3 Hemoglobin greater than 7.5 g/dL ALT less than ULN Estimated creatine clearance>50 mL/min as estimated by the Crockcroft-Gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85)) Female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception) Serum alpha-fetoprotein less than 50 ng/mL within 30 days of study entry Childs-Pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy able to give written informed consent and to comply with the study protocol Exclusion Criteria: history or evidence of HIV, hepatitis C or hepatitis D known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs. history of clinically significant renal dysfunction any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol pregnancy or breastfeeding receipt of systemic corticosteroids within 90 days of study entry receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Mono therapy
Combo therapy
Hepsera