A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children with Genotype 2 or 3 Chronic HCV Infection

Gilead Sciences, Inc.0 个研究点目标入组 100 人开始时间: 2014年7月21日最近更新: 2018年11月6日

试验速览

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•1) Positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Day 1 visit
•2) Liver biopsy performed prior to the Day 1 visit with evidence of chronic HCV infection
•3) Infection with HCV GT-2 or GT-3 as determined at Screening
•4) HCV RNA = 1000 IU/mL at Screening
•5) For the PK Lead-in Phase: subjects in cohort 1 (age 12 to <18 years of age) must weigh = 45kg
•6) For the PK Lead-in Phase: subjects in Cohort 2 (age 6 to < 12 years of age) must weigh = 17 kg and < 45 kg
•7) Females of childbearing potential (as defined in Appendix 5) must have a negative pregnancy test at Screening and Day 1.
•8) Hematologic or biochemical parameters at screening within the protocol-specified requirements
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) HIV, acute hepatitis A virus (HAV) or chronic HBV infection
•2) History of or current decompensated liver disease
•3) Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
•4) Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency)
•5) Chronic use of systemic immunosuppressive agents or immunomodulatory agents
•6) Active or recent history (= 1 year) of drug or alcohol abuse
•7) History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
•8) Sexually active subjects who are not willing to use two forms of an effective method of contraception as referenced in Appendix 5.

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