ISRCTN66069132已完成3 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
PARI Pharma GmbH (Germany)0 个研究点目标入组 130 人开始时间: 2008年7月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current information as of 31/03/2010:
- •The following point has been amended as of the above date:
- •2. Received a single lung, bilateral lung or heart/lung transplantation between 6 weeks and 26 weeks prior to first IMP administration
- •Previous information as of 12/05/2009:
- •1. Patient'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 medical product (IMP) administration
- •3. Male or female greater than or equal to 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:
- •6.1. 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
- •6.2. Mycophenolate mofetil (MMF) 1 to 3 g/day, and
- •6.3. Prednisone orally; tapered down within the first 3 months after transplantation
- •7. Female patients with childbearing 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.
- •8. Estimated life expectancy greater than 6 months
- •Initial information at time of registration:
- •1. Signed informed consent provided prior to any screening procedure
- •2. Male or female, 12 years or older
- •3. Capable of self-administrating medications
- •4. Capable of understanding the purpose and risk of the study
- •5. Received a single lung, bilateral lung or heart/lung transplantation within one week prior to first investigational medicinal product (IMP) administration
- •6. Received within one week prior to first IMP administration the following immunosuppressive agents and dosages for maintenance therapy:
- •6.1. Tacrolimus 0.1 to 0.2 mg/kg/day adjusted to target serum level (trough concentrations) of 8 to 15 µg/L
- •6.2. Mycophenolate mofetil (MMF) 1 to 3 g/day, and
- •6.3. Prednisone orally 0.5 mg/kg/day initial dosing tapered down to approximately 5 mg/week after 2 to 4 weeks
- •7. Female patients with child bearing 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 treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include intra-uterine device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository)
- •8. Estimated life expectancy greater than 6 months
排除标准
- •Current information as of 12/05/2009:
- •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
- •Initial information at time of registration:
- •1. Any previous episode of acute rejection of grade A2 or higher
- •2. Any previous episode of bronchiolitis obliterans (BO) or bronchiolitis obliterans syndrome (BOS) of grade 1 or higher
- •3. An active invasive bacterial, viral or fungal infection within one week prior to IMP administration
- •4. Received systemic maintenance immunosuppressive therapy other than listed in the inclusion criteria within one week prior to first IMP administration
- •5. Received any systemic or topical cyclosporin within one week prior to first IMP administration and/or during the clinical trial
- •6. Received mechanical ventilation
- •7. Received a lung re-transplantation
- •8. Pregnant or breast feeding woman
- •9. Has known hypersensitivity to cyclosporin A
- •10. Has a serum creatinine value of more than 3 mg/dL
- •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 subject's participation in the study
- •14. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- •15. Has been previously enroll
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