JPRN-jRCT2080225122已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
The Sponsor took the strategic decision to prematurely terminate the study, mainly due to very low participant recruitment. Therefore, insufficient data were available to draw any conclusions. No safety concerns were determined in the 3 participants enrolled in the study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 13age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using any conditioning regimen
- •- Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)
- •- Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization
- •- New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing
- •- Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent (%) on room air
排除标准
- •- Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator
- •- Requires supplemental oxygen at Screening or any time between Screening and randomization
- •- Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus) within 7 days prior to or at the Screening visit, if determined by local SOC testing (additional testing is not required)
- •- Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator
研究者
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