EUCTR2008-003800-73-BE进行中（未招募）1 期
A phase III, multicentre, randomised, double-blind, placebo controlled clinical trial to investigate the efficacy and safety of 10 or 20 mg/day aerosolised liposomal ciclosporin A (L-CsA) versus aerosolised placebo in the prevention of bronchiolitis obliterans syndrome (BOS) in lung transplant (LT) patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient’s written informed consent obtained prior to any screening procedure
- •2.Received a single lung, bilateral lung or heart/lung
- •transplantation between 6 weeks and 32 weeks prior to first IMP
- •administration
- •3.Male or female, >/= 18 years of age
- •4.Capable of self-administration of medications
- •5.Capable of understanding the purpose and risk of the clinical trial
- •6.Received within one week prior to first IMP administration the following immunosuppressive agents and dosages for maintenance therapy:
- •a) Tacrolimus and
- •b) Mycophenolate mofetil (MMF) 1 to 3 g/day and
- •c) Prednisone or any other steroid therapy; tapered down within the first 3 months after transplantation
- •7. Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration.
- •Both women and men must agree to use a medically acceptable method of contraception throughout the IMP treatment period and for 3 months after IMP discontinuation. Acceptable methods of contraception are disclosed in Appendix II
- •8.Estimated life expectancy > 6 months
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 190
排除标准
- •1.Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
- •2.Any active invasive bacterial, viral or fungal infection within one week prior to first IMP administration
- •3.Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria within one week prior to first IMP administration
- •4.Received any systemic or topical ciclosporin A within one week prior to first IMP administration and /or during the clinical trial
- •5 Received any systemic or topical Rosuvastatin within one week prior to first IMP administration and /or during the clinical trial
- •6.Current mechanical ventilation
- •7.Received a lung re-transplantation
- •8.Pregnant or breast feeding woman
- •9.Has known hypersensitivity to ciclosporin A
- •10.Has a serum creatinine value of more than 265 µmol/L (3 mg/dL) or chronic dialysis (haemodialysis)
- •11.Unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
- •12.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
- •13.Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the clinical trial
- •14.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- •15.Patient was previously enrolled in the present clinical trial
研究者
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