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 at least 6 months.
18 through 69 years of age, inclusive.
Active hepatitis B e-antigen (HBeAg) negative chronic HBV infection, with all of the following:
* HBeAg negative and HBeAb positive at screening
* Alanine aminotransferase (ALT) levels \> the upper limit of the normal range (ULN) and ≤ 10 x ULN
* Serum HBV DNA \> 100,000 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 120 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
Nucleotide naive, ie, no prior nucleotide (TDF or ADV) therapy for greater than 12 weeks
Nucleoside naive, ie, no prior nucleoside (any nucleoside) therapy for greater than 12 weeks. However, up to 120 patients with \> 12 weeks prior lamivudine experience will be eligible
Willing and able to provide written informed consent
Had a 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 women 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.
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)
Coinfection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D 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
Has proximal tubulopathy
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