An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 217 人开始时间: 2010年5月12日最近更新: 2016年3月14日

研究概览

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•- Subjects who have completed the assigned study treatment Study 102 or Study 103 who meet certain criteria.
•- Subjects who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770).
•- Subjects who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator.
•- Subjects of child bearing potential and who are sexually active must meet the contraception requirements.
•- Subjects must sign the informed consent form (ICF), and where appropriate, assent must be obtained.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 73
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 118
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Subjects with a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
•- Subjects with a history of study treatment intolerance as observed in their previous VX 770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject.
•- Subjects who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements.
•- Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications (e.g., St. John’s Wort) and grapefruit/grapefruit juice.

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