A long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable

PARI Pharma GmbH0 个研究点目标入组 180 人开始时间: 2011年12月19日最近更新: 2017年8月21日

研究概览

暂无简介。

•1.Patient has completed the L-CsA clinical trial 12011.201
•2.Patient is capable of understanding the purpose and risks of the follow-up study, has been fully informed and has given written informed consent to participate in the study
•3.Female patients of child bearing potential must test negative on standard urine pregnancy test prior to continuation and must agree to practice effective birth control during the study(see Appendix 3)
•4.Estimated life expectancy > 6 months
•5.Capable of self-administration of medications
•6.Patient has stable creatinine levels
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1.Patients with ongoing irreversible L-CsA related serious adverse events
•2.Patients with known hypersensitivity for ciclosporin A
•3.Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
•4.Patient receives mechanical ventilation
•5.Patients underwent pulmonary re-transplantation
•6.Patient is a pregnant or breast-feeding woman
•7.Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
•8.Patient receives any systemic or topical Rosuvastatin
•9.Patient has been previously enrolled in this study
•10.Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
•11.Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
•12.Patient is not eligible to continue IMP inhalation according to the Investigator’s discretion

发起方