EUCTR2019-001551-39-BG进行中（未招募）1 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 - FREESIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 249
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •1. Male or female.
- •2. 18 to 75 years of age, inclusive. Subjects =13 and <18 years of age may be enrolled in selected countries and study sites consistent with local regulations.
- •3. Received an autologous or allogeneic HSCT using any conditioning regimen.
- •4. ALC <1,000 cells/µL. The local assessment confirming ALC <1,000 cells/µL should be performed no more than 48 hours prior to randomization.
- •5. The participant has been diagnosed with RSV infection using a rapid PCR- or other molecular-based diagnostic assay performed on a bilateral mid-turbinate nasal swab sample as part of the study-specific screening assessment or on an upper respiratory tract sample as part of SOC testing.
- •6. New onset of at least 1 of the following respiratory symptoms within 4 days prior to the anticipated start of dosing (Day 1): nasal congestion, rhinorrhea, cough or pharyngitis (sore throat), and/or worsening of one of these chronic (associated with previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease) respiratory symptoms within 4 days prior to the anticipated start of dosing (Day 1).
- •7. No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist (preferentially) or the investigator. A chest X-ray should be performed no more than 48 hours prior to randomization. If a chest X-ray has not been obtained as part of SOC, it must be obtained during Screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •1. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator.
- •2. Requires supplemental oxygen at Screening or any time between Screening and randomization.
- •3. 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).
- •4. Clinically significant bacteremia or fungemia within 7 days prior to or at Screening that has not been adequately treated, as determined by the investigator.
- •5. Known allergies, hypersensitivity, or intolerance to JNJ-53718678 or its excipients.
- •6. Bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated, as determined by the investigator.
- •7. Criterion modified per Amendment 3:
- •7.1 Confirmed QTcF interval >450 milliseconds per the machine read parameter result at Screening. Presence of an abnormal QTcF interval should be confirmed by repeat ECG recording during Screening.
- •8. Criterion modified per Amendment 5:
- •8.1 Clinically significant abnormal ECG findings (other than QTcF interval >450 milliseconds, see exclusion criterion 7) not consistent with the underlying condition in the study population, as judged by the investigator based on the machine read ECG results at Screening.
- •9. Has evidence of one of the following ECG abnormalities per the machine read ECG results at Screening confirmed by repeat ECG recording: 1) Repetitive premature ventricular contractions (>10/min.); 2) Second- or third- degree heart block; 3) Complete or incomplete left bundle branch block or complete right bundle branch block
研究者
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