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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04254705
Eligibility Criteria:
Inclusion Criteria:
* In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Male or female with confirmed diagnosis of CF. The subject must have the following:
a. One or more characteristic phenotypic features, such as chronic cough and sputum production, persistent chest radiograph abnormalities, or airway obstruction manifested by wheezing and air trapping; or a history of CF in a sibling; or a positive newborn screening test result;
2. Two CFTR mutations identified of which one is R334W OR only the R334W mutation identified and a sweat chloride value above 60 mmol/L
3. Age 12 years and older
4. Subject will sign and date an informed consent form (ICF) and or assent (for subjects 12 to 16 years old).
Exclusion Criteria:
* A potential subject who meets any of the following criteria will be excluded from participation:
1. Subject has one of the following CFTR-mutations:
G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H, P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A\>G, S945L, S977F, R1070W, D1152H, 2789+5G\>A, 3272 26A\>G, 3849+10kbC\>T
2. A history of hemorrhoids and recent rectal bleeding
3. FEV1 above 90% predicted or below 30% predicted during stable disease
4. History of lung transplantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
99 Years
Study:
NCT04254705
Study Brief:
Protocol Section:
NCT04254705