Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
This is a Phase 3, multicenter, open-label and roll-over study in subjects who are 12 to <24
 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
Key Inclusion Criteria:

 -  Subjects From Study VX16-809-122 Part B (Study 122)

 -  Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study
 122B

 -  Subjects Not From Study 122

 -  Subjects will be 1 to less than 2 years of age

 -  Homozygous for the F508del mutation (F/F)

 Key Exclusion Criteria:

 -  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

 Other protocol defined Inclusion/Exclusion criteria may apply.