A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part A:
Participants entering the Treatment Cohort must meet all of the following criteria:
Elect to enroll in the Treatment Cohort
Completed study drug Treatment Period in a parent study (NCT02070744, NCT02347657, NCT02516410, NCT02392234, NCT02412111) or study drug treatment and the Safety Follow up Visit for participants from NCT02508207.
Willing to remain on a stable CF regimen through the Safety Follow-up Visit.
Participants re-enrolling in the Part A Treatment Cohort must meet all of the following criteria:
* Previously received at least 4 weeks of study drug before discontinuing in Part A of Study NCT02565914 to participate in another qualified Vertex study.
* Completed the last required visit of another qualified Vertex study before or during the Returning Visit in Part A Study NCT02565914.
Participants entering the Part A Observational Cohort must meet the following criteria:
* \<18 years of age (age on the date of informed consent/assent in the parent study)
* Completed study drug Treatment Period in a parent study or study drug treatment and the Safety Follow up Visit for subjects from NCT02508207, but do not elect to enroll in the NCT02565914 Treatment Cohort; or
* Received at least 4 weeks of study drug treatment and completed visits up to the last scheduled visit of the Treatment Period of a parent study (and the Safety Follow up Visit for participants from NCT02508207), but do not meet eligibility criteria for enrollment into the Treatment Cohort
Part B:
Did not withdraw consent from the parent study or Part A of Study NCT02565914.
Completed study drug treatment during the Treatment Period in Part A of - Willing to remain on a stable CF medication (and supplement) regimen through the 96 week visit of Study NCT02565914.
Participants re enrolling in Part B must meet all of the following criteria:
Previously received at least 4 weeks of study drug before discontinuing Study NCT02565914 to participate in another qualified Vertex study, which is defined as a Vertex study of investigational CFTR modulators that allows participation of participants in Study NCT02565914.
Completed the last required visit of another qualified Vertex study before or during the Returning Visit in Part B.
Willing to remain on a stable CF medication (and supplement) regimen through the 96 week visit in Part B.
Part C:
Did not withdraw consent from Part B of Study NCT02565914.
Completed study drug treatment during Part B of NCT02565914.
Willing to remain on a stable CF medication (and supplement) regimen through the 96 week visit of Part C.
You may not be if
History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
Pregnant and nursing females.
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
History of drug intolerance in the parent study that would pose an additional risk to the subject.
Participation in an investigational drug trial (including studies investigating VX-661/ivacaftor or lumacaftor/ivacaftor) other than the parent studies of NCT02565914 or other eligible Vertex studies investigating VX-661 in combination with ivacaftor, or use of a commercially available CFTR modulator.
Clareo Health | A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
