Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
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
1–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants From Study VX16-809-122 Part B (Study 122)
* Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B
Participants Not From Study 122
* Subjects will be 1 to less than 2 years of age
* Homozygous for the F508del mutation (F/F)
You may not be if
Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject
Solid organ or hematological transplantation
Clareo Health | Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation