Rollover Study of VX-770 in Cystic Fibrosis Subjects
Rollover Study of VX-770 in Cystic Fibrosis Subjects
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment
 in participants with cystic fibrosis (CF). The secondary objective of the study was to
 evaluate the efficacy of long-term VX-770 treatment in subjects with CF.
This open-label, rollover study of orally administered VX-770 was conducted in participants
 with CF to evaluate the safety and efficacy of long-term VX-770 treatment. Participants who
 were previously enrolled in Study 102 (VX08-770-102/NCT00909532) and Study 103
 (VX08-770-103/NCT00909727), and met certain criteria were eligible to enroll in this study
 (Study 105/VX08-770-105/NCT01117012).
Inclusion Criteria:

 1. Participants who have completed the assigned study treatment in Study 102 or Study 103

 2. Participants who are females of childbearing potential must have a negative urine
 pregnancy test on Day 1 (first dose of VX-770)

 3. Participants 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

 4. Participants of child bearing potential and who are sexually active must meet the
 contraception requirements

 5. Participants must sign the informed consent form (ICF), and where appropriate, assent
 must be obtained

 Exclusion Criteria:

 1. Participants 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

 2. Participants 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

 3. Participants who are pregnant, planning a pregnancy, breast-feeding, or not willing to
 follow contraception requirements

 4. Participants taking any inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4),
 including certain herbal medications (for example, St. John's Wort) and
 grapefruit/grapefruit juice