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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04702360
Eligibility Criteria:
Key Inclusion Criteria:
* Patients with confirmed diagnosis of CF who have an F/any genotype
* Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
* Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) \<40 for a minimum of 60 consecutive days before the date of completion of the request form
Key Exclusion Criteria:
* Patients with severe hepatic impairment
Other protocol-defined inclusion/exclusion criteria may apply
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT04702360
Study Brief:
Protocol Section:
NCT04702360