Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline
Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
Positive or negative for hepatitis B e antigen (HBeAg)
HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants)
Alanine aminotransferase (ALT) \> 54 U/L and ≤ 400 U/L for men and \> 36 U/L and ≤ 300 U/L for women
Creatinine clearance ≥ 70 mL/min
Negative serum pregnancy test for females of childbearing potential
Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication
Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product
You may not be if
Known bridging fibrosis or cirrhosis and/or decompensated liver disease
Evidence of hepatocellular carcinoma
Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures)
History of severe depression or severe psychiatric disease
Thyroid dysfunction
Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
Pregnant
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