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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT02141958
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent
* Males or females
* 18 years and older
* Diagnosis: Patients must have a diagnosis of cystic fibrosis (positive sweat chloride test) or confirmation of two genetic mutations, one mutation on each of the two alleles of the Cystic fibrosis transmembrane conductance regulator (CFTR) gene causing Cystic Fibrosis
* Chronic cystic fibrosis lung disease with baseline Forced Exploratory Volume in one second equal or superior to 40% predicted value for age, gender and height
* Clinically stable patients will be enrolled in the study, i.e. stable at least one month after successful treatment of pulmonary exacerbation
* Chronic pulmonary Pseudomonas aeruginosa colonization and/or infection (sustained microbiological evidence from sputum for the past 6 months, prior to enrollment)
* Pancreatic function: Patient must take pancrelipase supplementation if diagnosed with pancreatic insufficiency as prescribed by a physician. Enzyme supplementation should not be modified during the trial
* Female patients should be on an effective contraceptive method during the study.
Exclusion Criteria:
* Pregnancy : due to the potential teratogenic effects of retinoids, pregnant women are NOT eligible
* Breastfeeding by study patient is NOT allowed
* Clinically abnormal renal function: Serum Creatinine \> 132 micromoles/L
* Clinically abnormal liver function: Total bilirubin \>1.5 x Upper Limit of the Normal range (ULN), Alanine Aminotransferase (ALT) and/or Aspartate AminoTransferase (AST) \> 3 x ULN and Alkaline Phosphatase (ALP) \> 2 x ULN
* Known history of a severe allergy or sensitivity to retinoids
* Presence of a cancerous tumor, active or in remission, treated or not
* Presence of nyctalopia or hemeralopia at enrolment, or any other serious retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis and xerophthalmia), including glaucoma
* Presence of serious dermatological conditions at entry, including inflammatory or xerotic pathologies such as psoriasis or ichthyosis
* Prior therapy with Fenretinide. Other retinoids (eg: vitamin A supplements) are allowed, but their dosing regimen should remain constant throughout the study
* Participation in another drug clinical trial within 30 days prior to the enrollment
* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
* Patients unable to comply with the study protocol and follow-up schedule for any psychological, familial, sociological or geographical reason.
* Patients with known allergies to excipients in the oral capsule formulation proposed to be used in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02141958
Study Brief:
Protocol Section:
NCT02141958