Overview

Rollover Study of VX-770 in Cystic Fibrosis Subjects

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborators:
Cystic Fibrosis Foundation
Cystic Fibrosis Foundation Therapeutics
Treatments:
Ivacaftor
Criteria
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