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 hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
18 through 69 years of age, inclusive
Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
* HBeAg positive at screening
* Alanine aminotransferase (ALT) levels \> 2 × ULN and ≤ 10 × the upper limit of the normal range (ULN)
* Serum HBV DNA \> 1 million copies/mL at screening
* creatinine clearance ≥ 70 mL/min
* hemoglobin ≥ 8 g/dL
* neutrophils ≥ 1,000 /mL
Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score \< 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
Nucleotide naïve, ie, no prior nucleotide (TDF or ADV) therapy for \> 12 weeks
Nucleoside naïve, ie, no prior nucleoside (any nucleoside) therapy for \> 12 weeks
Willing and able to provide written informed consent
Liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
You may not be if
Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
Males and females of reproductive potential who are unwilling to use an effective method of contraception during 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 \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
Received any nucleoside, nucleotide (TDF or ADV) or interferon (pegylated or not) therapy within 6 months prior to the pre-treatment biopsy
Evidence of hepatocellular carcinoma (HCC), ie, α-fetoprotein \>50 ng/mL
Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV)
Significant renal, cardiovascular, pulmonary, or neurological disease
Received solid organ or bone marrow transplantation
Is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
