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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02722057
Eligibility Criteria:
Inclusion Criteria:
Non Interventional Cohort
* Male or female with confirmed diagnosis of CF
* Must have at least 1 allele of the R117H-CFTR mutation
* Enrolled in the US CFF Patient Registry
* With a record of Kalydeco treatment initiation from 01 January 2015 through 31 December 2016
Historical Cohort
* Patients with CF in the CFF Patient Registry as of 01 January 2009
* Must have at least 1 allele of the R117H-CFTR mutation
* Patients with no evidence of any prior Kalydeco exposure
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02722057
Study Brief:
Protocol Section:
NCT02722057