None listed
Conditions
Brief summary
Study 105 (VX08-770-105) is an open-label, VX-770 treatment extension of Study VX08-770-102 (Study 102) and Study VX08-770-103 (Study 103). This rollover study evaluates the long-term safety and efficacy of treatment with the experimental drug, VX-770, for a duration of up to 96 weeks. Male and female subjects 6 years and older with cystic fibrosis who have completed Study 102 or 103 without major protocol violations are eligible to enrol. This project is an international, multi-centre trial, with subjects from 70 sites worldwide including Australia, Europe and North America. [Study 102: NCT00909532] [Study 103: NCT00909727]
Interventions
VX-770 150mg, oral tablets, twice per day, for the sooner of approximately 96 weeks or until VX 770 is commercially available in each respective country
Sponsors
Vertex Pharmaceutical Incorporated
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who have completed the assigned study treatment Study 102 or Study 103. 2. Subjects who are female of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770) 3. 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. 4. Subjects of childbearing potential and who are sexually active must meet the contraception requirements. 5. Subjects must sign the informed consent form (ICF), and where appropriate, assent must be obtained.
Exclusion criteria
1. 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. 2. 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. 3. Subjects who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements. 4. Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications (e.g., St John's Wort) and grapefruit/grapefruit juice.
Outcome results
None listed