Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

Key facts

Study ID

NCT01707290

Run by

Vertex Pharmaceuticals Incorporated

People needed

125

Starts

2013-02-01

Expected to finish

2016-04-01

Last updated by the study team

2017-05-12

Who can join

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

You may qualify if…

• Participants from Study 110 or Study 111 entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study.
• Participants from Study 113 entering the ivacaftor arm must have completed all study related treatments through the Follow-up Visit and met the Study 113 responder criteria during the previous study.
• Participants entering the observational arm must have completed at least 4 weeks of study drug treatment in their previous study (Study 110 or Study 111), must have completed the previous study but do not wish to enroll in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm.
• Participants of childbearing potential entering the ivacaftor arm must not be pregnant.
• Participants entering the ivacaftor arm must be willing to comply with contraception requirements.
• Exclusion Criteria (Ivacaftor Arm Only):
• History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the Participant.
• Use of moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A.
• Evidence of cataract or lens opacity at or before the Day 1 Visit.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Palo Alto, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lexington, Kentucky, 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 — Grand Rapids, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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