A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects with Chronic Hepatitis B and who are currently not on Treatment

Gilead Sciences, Inc.0 个研究点目标入组 175 人开始时间: 2014年7月25日最近更新: 2019年1月7日

适应症

试验速览

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•Subjects must meet all of the following inclusion criteria to be eligible to participate in the study.
•1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
•2. Adult male or non-pregnant, non-lactating female subjects, =18 years of age, based on the date of the screening visit
•3. Documented evidence of chronic HBV infection
•4. Screening HBV DNA = 2000 IU/mL
•5. The Body mass index (BMI) must be = 18 kg/m2
•6. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
•7. Lactating females must agree to discontinue nursing before the Investigational Medicinal Product (IMP) is administered
•8. A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal)
•9. Must be willing and able to comply with all study requirements
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 165
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Subjects who meet any of the following exclusion criteria are not eligible to participate in the study.
•1. Cirrhosis and advanced bridging fibrosis
•3. Co-infection with HCV, HIV or HDV
•4. Received antiviral treatment for HBV within 3 months of screening
•5. Evidence of hepatocellular carcinoma
•6. Significant cardiovascular, pulmonary, or neurological disease
•7. Women who may wish to become pregnant during the course of the study
•8. Male subjects unwilling to refrain from sperm donation for at least 90 days after the last dose of GS-4774
•9. Received solid organ or bone marrow transplant
•10. Received prolonged therapy with immunomodulators within 3 months of screening
•11. Use of investigational agents within 3 months of screening
•12. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
•13. Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
•14. History of demyelinating disease (Guillain-Barre), Bell’s Palsy, Crohn’s disease, Ulcerative colitis, or automimmune disease
•15. Documented history of yeast allergy
•16. Known hypersensitivity to study drugs, metabolites or formulation excipients
•17. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection
•18. Believed by the study Investigator to be inappropriate for study participation for any reason

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