NCT00658086已完成2 期
A Multi-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
研究概览
简要总结
To evaluate the safety,tolerability and antiviral activitity of ALN-RSV01 in RSV infected lung transplant patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single or bilateral lung transplant recipients
- •Confirmed RSV infection
- •Greater than 90 days post current lung transplant
- •Rejection free for a minimum of 1 month
排除标准
- •Antimicrobial therapy for known viral, bacterial, or fungal respiratory co-infection at the time of diagnosis
- •Bronchiolitis obliterans syndrome (BOS) Grade 3 or any state BOS with FEV1 that has not been stable for at least 3 months
- •Use of alemtuzumab within 9 months prior to screening; anti-thymocyte globulin(ATG) or thymoglobulin within 3 months of screening: concurrent use of >= 0.3 mg/kg/day prednisone or equivalent as maintenance therapy
- •active treament for acute graft rejection
研究组 & 干预措施
1
Active Comparator
ALN-RSV01
干预措施: ALN-RSV01 (Drug)
2
Placebo Comparator
Normal saline
干预措施: normal saline (Drug)
结局指标
主要结局
Assess safety and tolerability of aerosolized ALN-RSV01 versus placebo in lung transplant patients infected with RSV
时间窗: Day 30
次要结局
- Evaluate effects of ALN-RSV01 on clinical and virologic endpoints(Throughout Trial)
研究者
研究点 (1)
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