NCT01889017Unknown不适用
Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Frequency of use of generic immunosuppressive drugs
研究概览
简要总结
Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation
详细描述
Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors.
For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients after lung transplantation (single, double or combined)
- •informed consent
- •patient with an immunosuppressive therapy with tacrolimus or ciclosporin
排除标准
- •immunosuppressive therapy without calcineurin inhibitors
- •need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus[MRSA), B. cenocepacia)
- •limited German language skills or other reasons which might impair patient communication or computer handling
结局指标
主要结局
Frequency of use of generic immunosuppressive drugs
时间窗: baseline
次要结局
- Calcineurin inhibitor through levels(baseline, retrospective 6 months)
- Dose of calcineurin inhibitors(baseline)
- Therapy adherence(baseline)
- Satisfaction with immunosuppression(baseline)
研究者
Thomas Fuehner
MD
Hannover Medical School
研究点 (1)
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