A Randomized, Double Blind, Placebo Controlled Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans Syndrome in Bilateral Lung and Single Lung Transplant Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
研究概览
简要总结
The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
详细描述
The objective of this study is to evaluate the efficacy and safety of basiluximab for the prevention of acute allograft lung rejection when used in addition to Neoral, corticosteroids and azathioprine. Acute rejection episodes will be evaluated during the first 6 months post-transplant. Bronchiolitis obliterans syndrome (BOS) will be evaluated at the end of 1 year after transplant and at additional follow-up visits at 2 and 3 years after transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients who require immunosuppressive therapy other than the study medications.
- •Patients participating in another (investigational) drug trial or who have participated in such a study within 30 days prior to transplantation.
- •Pregnant mothers, nursing women.
- •Women unwilling to use adequate contraception during and for 3 months after receiving study drug.
- •Patients receiving or requiring other investigational drugs, except antibiotics.
- •Patients with current or past peak panel reactive antibody levels of 25% or greater.
- •Patients with malignancy or history of malignancy other than successfully treated non-metastatic basal cell or squamous cell carcinoma of the skin.
- •Patients with any form of substance abuse or psychiatric disorder which, in the opinion of the investigator, might invalidate patient communication with the clinician(s).
- •Patients who have previously received Simulect.
研究组 & 干预措施
basiliximab
干预措施: basiliximab (Drug)
placebo
干预措施: placebo (Other)
结局指标
主要结局
The proportion of patients who experience one or more acute allograft rejections in the first six months of treatment.
次要结局
- The proportion of patients who experience one or more acute allograft rejections by 1 year post-transplantation.