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
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects entering the Treatment Cohort must meet both of the following criteria:
Completed study visits up to Week 24 of Study 109 or Week 26 of Study 011B and did not permanently discontinue treatment
Willing to remain on a stable CF medication through the Safety Follow-up Visit.
Subjects entering the Observational Cohort must meet 1 of the following criteria:
Completed 24 weeks of study drug treatment in Study 109 or completed 24 weeks of study drug treatment and the Week 26 Safety Follow up in Study 011B.
Received at least 4 weeks of study drug and completed visits up to Week 24 of Study 109 or Week 26 of Study 011B.
You may not be if
History of any comorbidity or laboratory abnormality 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 (e.g., cirrhosis with portal hypertension).
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 prior study that would pose an additional risk to the subject in the opinion of investigator
History of poor compliance with study drug and/or procedure in the previous study as deemed by the investigator.
Participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor).
