EUCTR2008-003801-15-BE进行中（未招募）1 期
A phase II, randomised, double-blind, placebo controlled, parallel group,dose-finding clinical trial to investigate the efficacy and safety of 10 and 20mg/day aerosolised liposomal ciclosporin A (L-CsA) versus placebo in thetreatment of bronchiolitis obliterans syndrome (BOS) in allogeneichaematopoietic stem cell transplant (HSCT) patients
PARIPharma GmbH0 个研究点目标入组 70 人开始时间: 2009年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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. For subjects below 18 years of age, the written informed consent is obtained from the subject’s legal representative
- •2.Received an allogeneic haematopoietic stem cell transplantation (HSCT)
- •3.Has a baseline FEV1 value available prior to HSCT according to Appendix III
- •4.Has a diagnosis of bronchiolitis obliterans (BOS) of grade 1, 2 or 3 and confirmation to initiate BOS-specific treatment based on declining FEV1 values according to Appendix III within 1 week prior to first IMP administration
- •5.Male or female, >/= 12 years of age
- •6.Capable of self-administration medications
- •7.Capable of understanding the purpose and risk of the clinical trial
- •8.Received at least 1 week prior to first IMP administration the following immunosuppressive agents and dosages for the treatment of chronic graft-versus-hostdisease (GVHD) including BOS:
- •a)Tacrolimus approximately 0.1 to 0.2 mg/kg/day adjusted to a target trough serum level (C0) of 5 to 15 µg/L
- •b)Prednisone 1 to 3 mg/kg/day for 2 to 6 weeks, tapered down subsequently
- •9.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
- •10.Estimated life expectancy > 6 months
- •Are the trial subjects under 18? yes
- •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. Received systemic or topical ciclosporin A within one week prior to IMP administration and during the clinical trial
- •2.Any active invasive bacterial, viral or fungal infection within one week prior to first IMP admiistration
- •3.Received systemic immunosuppressive therapy for chronic GVHD other than listed in the inclusion criteria within one week prior to first IMP administration
- •4.Has steroid-refractory or steroid-intolerant chronic GVHD due to insulin-dependent diabetes or symptomatic avascular necrosis
- •5.Current mechanical ventilation
- •6.Pregnant or breast-feeding woman
- •7.Has a known hypersensitivity to ciclosporin A
- •8.Has a serum creatinine value of more than 265 µmol/L (3 mg/dL) or chronic dialysis (haemodialysis)
- •9.Unlikely to comply with the visits, inhalation procedures or spirometric measurements scheduled in the protocol
- •10.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
- •11.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
- •12.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- •13.Subject was previously included in the present clinical trial
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