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Completed
NCT07841353
Impact of Trikafta on P2X7R and Clinical Outcomes in Cystic Fibrosis
Conditions: Cystic Fibrosis (CF)
Sex: All
Ages: 5 Years – N/A
Healthy volunteers: No
Enrollment: 35
Sponsor: Ain Shams University
Location: Ain Shams University Hospitals Cairo Cairo Governorate
Summary
The aim of this study is to assess the response of the ETI on P2X7R level as inflammatory marker and clinical outcomes in patients with cystic fibrosis.
Eligibility Criteria
Inclusion Criteria:
* Confirmed diagnosis of Cystic Fibrosis according to CF Foundation guidelines (based on positive sweat chloride test and/or presence of disease-causing mutations in homozygous state or compound heterozygous state in CFTR gene).
* Patients eligible for ETI therapy (having at least one F508del mutation or a mutation known to be responsive to ETI).
* Age above 5 years old.
Exclusion Criteria:
* Known allergy or hypersensitivity to ETI or any of its components.
* Moderate hepatic impairment (Child-Pugh Class B) or severe hepatic impairment (Child-Pugh Class C).
* Presence of chronic inflammatory diseases unrelated to CF (e.g., Crohn's disease, glomerulonephritis, or thrombotic disorders) that could confound P2X7R levels.
Source: ClinicalTrials.gov (NCT07841353). StuddyBuddy aggregates publicly available trial information.