Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02848560
Eligibility Criteria:
Inclusion Criteria:
Treatment group:
* male or female between the ages of 6 through 12 years at enrollment
* two copies of the F508del CFTR mutation
* anticipated to be a candidate for treatment with orkambi
Control group:
* male or female between the ages of 6 through 12 years at enrollment
* two non-functional CFTR mutations with one of them being F508del CFTR mutation
* not eligible for CFTR modulation therapy
Exclusion Criteria:
* FEV1 percent predicted of \<60%
* standard MRI exclusions (metal implants, claustrophobia)
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02848560
Study Brief:
Protocol Section:
NCT02848560