JPRN-jRCT2031210527已完成2 期
A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSVrelated Disease Progression - PRIMROSE
akama Takahiro0 个研究点目标入组 5 人开始时间: 2021年12月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
The study was terminated early due to sponsor's strategic decision to discontinue the development of rilematovir. This decision was not due to safety concerns but driven by challenges in recruiting patients within 3 days after onset of symptoms and the limited clinical benefit observed thus far. Insufficient data were available to perform any meaningful analyses and no conclusions could be drawn. No safety concerns were identified in the 4 participants on rilematovir treatment enrolled in the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus(RSV) infection
- •- Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least `moderate` if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms preexisted
- •- Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample
- •- Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a.age greater than or equal to (>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
- •- Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms
- •- Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than [<] 24 hours are not considered as hospitalization)
排除标准
- •- Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation
- •- Presence of clinically significant heart arrhythmias,uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia
- •- Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection
- •- Immunocompromised conditions
- •- Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
研究者
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