A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon Î±-2a (PegasysÂ®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon Î±-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B(CHB)

Gilead Sciences Inc0 个研究点目标入组 720 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline
•2.Anti-HBV treatment naÃ¯ve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose >= 24 weeks prior to screening are also eligible.
•3.Positive or negative for HBeAg
•4.HBV DNA >= 20,000 IU/ml for HBeAg+ subjects and HBV DNA >= 2,000 IU/ml for HBeAg- subjects
•5.ALT > 54 U/L and <= 400 U/L for men and > 36 U/L and <= 300 U/L for women
•6.Creatinine clearance (CLcr) >= 70 mL/min
•7.A negative serum pregnancy test is required for female subjects of childbearing potential.
•8.All sexually active female subjects of childbearing potential must agree to use a protocol-recommended method of contraception during heterosexual intercourse throughout the study and for 30 days following the last dose of study medication .
•9.Lactating female subjects must agree to discontinue nursing before initiation of study investigational medicinal product.

•1.Known bridging fibrosis or cirrhosis and/or decompensated liver disease
•2.Absolute neutrophil count 1,500/mm3, platelet 100,000/mm3, hemoglobin 10 g/dL (female) or 11 g/dL (male)
•3.Evidence of hepatocellular carcinoma
•4.History of severe depression or known severe psychiatric disease
•5.History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, history of multiple bone fractures)
•6.Thyroid dysfunction
•7.Pregnant
•8.Co-infection with HIV, HCV or HDV

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