Rollover Study of VX-770 in Cystic Fibrosis Subjects

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01117012

Run by

Vertex Pharmaceuticals Incorporated

People needed

192

Starts

2010-07-01

Expected to finish

2014-05-01

Last updated by the study team

2015-07-07

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who have completed the assigned study treatment in Study 102 or Study 103
• Participants who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770)
• 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
• Participants of child bearing potential and who are sexually active must meet the contraception requirements
• Participants must sign the informed consent form (ICF), and where appropriate, assent must be obtained

You may not qualify if…

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

Where it is running

• Study site — Oakland, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Long Branch, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New Hyde Park, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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