Chronic Hepatitis B MedDRA version: 8.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Sponsors
Gilead Sciences Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 through 69 years of age, inclusive • Chronic HBV infection, defined as positive serum HBsAg for at least 6 months • Active chronic HBV infection with all the following: - Currently treated with adefovir dipivoxil 10 mg QD (for = 24 weeks but = 96 weeks) - HBeAg positive or negative at screening - Plasma HBV DNA = 1000 copies/mL at screening (irrespective of HBeAg status) - Serum ALT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study. • Male or females of reproductive potential who are unwilling to use an effective method of contraceptive while enrolled in the study. For males, condoms should be used and for females, a barrier contraception method should be used. • Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets 50 ng/mL or by any other standard of care measure. • Co-infection with HCV (based on serology), HIV, or HDV. • Significant renal, cardiovascular, pulmonary, or neurological disease. • Received solid organ or bone marrow transplantation. • Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion. • Has proximal tubulopathy • Known hypersensitivity to tenofovir DF or emtricitabine/tenofovir DF, tenofovir or emtricitabine or their phosphorylated forms, or study drug product formulation excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the antiviral activity of tenofovir DF 300 mg QD versus emtricitabine 200 mg/tenofovir DF 300 mg QD in subjects currently being treated with adefovir dipivoxil for CHB who have persistent viral replication.;Secondary Objective: To evaluate the safety and tolerability of tenofovir DF 300 mg QD versus emtricitabine 200 mg/tenofovir DF 300 mg QD in subjects currently being treated with adefovir dipivoxil for CHB who have persistent viral replication. To evaluate and compare the incidence of drug resistance mutations in HBV DNA polymerase in both treatment arms. ;Primary end point(s): The primary endpoint is the proportion of subjects with plasma HBV DNA < 169 copies/mL at Week 48. | — |
Countries
Germany, Spain
Outcome results
None listed