NCT03468829撤回2 期
A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
Ablynx, a Sanofi company5 个研究点 分布在 3 个国家开始时间: 2019年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 5
- 主要终点
- Time-weighted average change from baseline in log10 RSV nasal viral load
研究概览
简要总结
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT).
The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT)
- •Subject is clinically diagnosed with RSV infection with new onset or acute worsening
- •Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization.
- •Documented RSV infection in the upper respiratory tract (URT)
- •Subject has:
- •Diagnosis of RSV lower respiratory tract (LRT) disease or
- •Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI)
- •Others as defined in the protocol
排除标准
- •Subject has clinically significant bacteremia or fungemia within 7 days of screening
- •Subject has clinically significant bacterial, fungal or viral pneumonia
- •Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment
- •Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration.
- •Others as defined in the protocol
研究组 & 干预措施
ALX-0171 Dose 2
Experimental
干预措施: ALX-0171 Dose 2 (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
ALX-0171 Dose 1
Experimental
干预措施: ALX-0171 Dose 1 (Biological)
结局指标
主要结局
Time-weighted average change from baseline in log10 RSV nasal viral load
时间窗: From Day 1 to Day 7
次要结局
- Number of days without oxygen or with oxygen supplementation(From Day 1 to Day 42)
- Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline(From Day 1 to Day 42)
- Concentration of ALX-0171 in serum(Day 1 to Day 14)
- Nasal RSV load parameter: time to undetectable shedding(From Day 1 to Day 42)
- Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum(From Day 1 to Day 42)
- Safety as measured by the incidence of treatment-emergent (serious) adverse events(From Screening to Day 42)
- Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)(From Day 1 to Day 42)
研究者
研究点 (5)
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