EUCTR2008-003800-73-DK进行中（未招募）不适用
A phase II, multicentre,randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 134
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. Subject’s written informed consent obtained prior to any screening procedure. 2.Received a single lung, bilateral lung or heart/lung transplantation within four weeks prior to first investigational medicinal product (IMP) administration
- •3.Male or female, >/= 18 years of age
- •4.Capable of self-administration 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 approximately 0.1 to 0.2 mg/kg/day adjusted to a target serum level (C0, trough) of 8 to 15 µg/L and
- •b) Mycophenolate mofetil (MMF) 1 to 3 g/day and
- •c) Prednisone orally; tapered down within the first 3 months after transplantation
- •7.Female patients with reproductive potential must have a negative serum pregnancy test within 3 days prior to screening. 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 of the protocol.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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. Current mechanical ventilation
- •6. Received any systemic or topical Rosuvastatin within one week prior to the first IMP administration and/or during the clinical trial
- •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 the 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 subject’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. Subject was previously included in the present clinical trial
研究者
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