A low-intervention prospective-retrospective study to evaluate the pharmacokinetics of elexacaftor/tezacaftor/ivacaftor combination in a Cystic Fibrosis population

2024-518785-28-00 · tracked via the Priya Life Science EU tracker

Sponsor

IRCCS Istituto Giannina Gaslini

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Decision date

24/09/2025

Enrollment target

Sites

Italy

Condition studied

Cystic Fibrosis

Investigational medicinal product(s)

Kaftrio 37.5 mg/25 mg/50 mg film-coated tabletsKalydeco 75 mg film-coated tabletsKalydeco 150 mg film-coated tabletsKaftrio 75 mg/50 mg/100 mg film-coated tablets

Eligibility

Age group

0-17 years, 65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Plasma concentrations of ELX, TEZ and IVA at steady-state (Css).

Endpoint detail

Population pharmacokinetics (popPK) analysis of ELX, TEZ and IVA at steady state., Harvest of every AE/Adverse Drug Reaction (ADR)., Correlation between PK of ELX, TEZ and IVA and number of AEs, Correlation between PK and ETI efficacy (ppFEV1 and Cl- values at T0) in the 3 groups classifications (responders, non responders and unresolved responders) of ETI

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-518785-28-00 on CTIS ↗ ← All trials in the EU