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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02465450
Eligibility Criteria:
Inclusion Criteria:
* Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test;
2. Two well-characterized mutations in the CFTR gene
* FEV1 ≥ 40% predicted corrected
* Stable treatment of CF for 14 days before Visit 1
Exclusion Criteria:
* Severe or unstable CF, such as:
1. Intravenous antibiotic treatment within 14 days before Visit 1
2. Treatment with any corticosteroids \> 10 mg per day or \> 20 mg every other day oral prednisone or equivalent within 14 days before Visit 1
* Any one of the following values for laboratory tests at Screening:
1. A positive pregnancy test (or at Visit 1);
2. Hemoglobin \< 10 g/dL
3. Neutrophils \< 1.0 x 10\~9/L
4. Platelets \< 75 x 10\~9/L
5. Creatinine clearance \< 50 ml/min according to modified Cockcroft-Gault equation
6. Serum transaminases \> 2.5 x upper normal limit
7. Total bilirubin ≥ 1.5 x upper limit of normal
* Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02465450
Study Brief:
Protocol Section:
NCT02465450