NCT01439958终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
研究概览
简要总结
The purpose of this study is to evaluate long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS) following lung transplantation (LTx) in patients previously enrolled in phase II/III L-CsA clinical trial 12011.201.
详细描述
This is an uncontrolled extension study open only to patients who completed the Phase II/III core study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy.
Determination of long-term safety and efficacy outcome over a maximum of three years will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has completed the L-CsA clinical trial 12011.201
- •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
- •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
- •Estimated life expectancy > 6 months
- •Capable of self-administration of medications
- •Patient has stable creatinine levels
排除标准
- •Patients with ongoing irreversible L-CsA related serious adverse events
- •Patients with known hypersensitivity for ciclosporin A
- •Patient intends to participate in another IMP clinical trial other than listed in the inclusion criteria
- •Patient receives mechanical ventilation
- •Patients underwent pulmonary re-transplantation
- •Patient is a pregnant or breast-feeding woman
- •Patient is unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
- •Patient receives any systemic or topical Rosuvastatin
- •Patient has been previously enrolled in this study
- •Patient with malignancy diagnosed during study 12011.201 (with the exception of skin cancer)
- •Documented respiratory infections unless on appropriate antimicrobial therapy with evidence of clinical response
- •Patient is not eligible to continue IMP inhalation according to the Investigator's discretion
研究组 & 干预措施
L-CsA
Experimental
Twice daily inhalation of L-CsA
干预措施: Inhalation (Drug)
结局指标
主要结局
Long-term safety of L-CsA in prevention of bronchiolitis obliterans syndrome (BOS)
时间窗: 3 years
Safety will be assesses by the numbers of treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) and overall rate of mortality.
次要结局
- Long-term efficacy outcome over a maximum of three years of patients previously enrolled in phase II/III L-CsA clinical trial 12011.201(3 years)
研究者
研究点 (1)
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