Cystic Fibrosis
Conditions
Brief summary
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Interventions
DRUGELX/TEZ/IVA
Fixed-dose combination granules for oral administration.
DRUGIVA
Granules for oral administration
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study Key
Exclusion criteria
* History of drug intolerance in the parent study that would pose an additional risk to the participant * Current participation in an investigational drug trial other than the parent study Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 100 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute Change in Sweat Chloride (SwCl) | From Baseline through Week 96 |
Countries
Australia, Canada, Denmark, Germany, Netherlands, Switzerland, United Kingdom
Outcome results
None listed