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Extension Study of Ataluren (PTC124) in Cystic Fibrosis
Bu çalışma, önceki bir Ataluren (PTC124) Faz 3 çalışmasını tamamlamış Kistik Fibroz (Cystic Fibrosis) hastalarında ilacın uzun dönem kullanımını (uzatma çalışması) inceliyor. Önceki çalışmayı tamamlamış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Completion of blinded study drug treatment in the previous Phase 3 study (PTC124-GD-009-CF). * Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if \<18 years of age). * In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period. * Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions. Exclusion Criteria: * Known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites). * Current pregnancy or lactating, or pregnancy or lactating during the previous Phase 3 study. * Ongoing participation in any other therapeutic clinical trial. * Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.