A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic HBV infection, defined as positive serum HBsAg for at least 6 months or HBsAg positive \> 3 months and positive for immunoglobulin G antibody against hepatitis B core antigen
18 through 69 years of age, inclusive
Hepatitis B e antigen (HBeAg) positive
HBV DNA ≥ 10\^8 copies/mL
ALT ≤ the upper limit of the normal range (ULN)
Willing and able to provide written informed consent
No prior oral HBV therapy (eg, nucleotide and/or nucleoside therapy or other investigational agents for HBV infection)
You may not be if
Pregnant women, women who were breast feeding, or who believed they may have wished to become pregnant during the course of the study
Males and females of reproductive potential unwilling to use an effective method of contraception during the study
Decompensated liver disease defined as direct (conjugated) bilirubin \> 1.2 x ULN, prothrombin time \> 1.2 x ULN, platelets \< 150,000/mm\^3, serum albumin \< 3.5 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, or variceal hemorrhage)
Received interferon (pegylated or not) therapy within 6 months of the screening visit
Alpha-fetoprotein \> 50 ng/mL
Evidence of hepatocellular carcinoma
Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus
Significant renal, cardiovascular, pulmonary, or neurological disease
Received solid organ or bone marrow transplantation
Was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Had proximal tubulopathy
Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Clareo Health | A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)
