Lumacaftor/Ivacaftor Population Pharmacokinetics in Pediatric Patients with Cystic Fibrosis: A First Step Toward Personalized Therapy

Funding

The study was supported by a grant from the French Ministry of Health (PHRC 2017, PREDICT-CF). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests

The authors have no competing interests to declare in relation to this work.

Ethics approval

This study was approved by the institutional review board (Comité de Protection des Personnes, Nord Ouest IV, no. EUDRACT: 2018-002624-16) and registered in the clinicaltrails.gov database under reference NCT03894657.

Consent to Participate

Written, informed consent was obtained from all participants or their guardians.

Consent for publication

Not applicable.

Data availability statement

Data from this study cannot be shared publicly, as the procedures carried out with the French data privacy authority [Commission nationale de l'informatique et des libertés (CNIL)] do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation of the data by other interested researchers may be considered by AP-HP, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable French and European regulations. The request must be addressed to the Delegation for Clinical Research and Innovation (DRCI) at secretariat-direction.drc@aphp.fr.

Code availability

Not applicable.

Author contributions

NB, JMT, and ISG contributed to the study conception and design. Material preparation, data collection, and analysis were performed by NB, SU, FF, LC, GL, LFD, SR, YZ, NS, KB, TB, ECD, CM, ED, ML, PR, MG, MM, RE, CT, LW, RB, MS, SB, and ISG. The first draft of the manuscript was written by NB, EB, ISG, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

留言 (0)

沒有登入
gif