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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT03894657
Eligibility Criteria:
Inclusion Criteria:
* Homozygous F508del patient aged 5 years or older
* Patient with an indication for Orkambi® treatment according to the marketing authorization application
* Patient never received Orkambi® in the past
* Patient able to perform FEV1
* Signed Informed consent form by the patient (if aged ≥ 18 years), or by parents / legal guardian and patient's agreement (if aged \< 18 years) Patient affiliated to the health insurance system
Exclusion Criteria:
* Homozygous F508del patients who do not meet the treatment indications according to the marketing authorization application
* Patients refusing Orkambi®
* CF patients not homozygous for the p.Phe508del mutation
* Active smoker
* Severe nasal mucosa disrepair
* Contraindications to xylocaine anesthesia,
* Participation with another interventional study with drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT03894657
Study Brief:
Protocol Section:
NCT03894657