CTIS2023-504425-39-00进行中（未招募）1 期
C5241009 - An interventional, Phase 1b, randomized, double-blind, sponsor-open, placebo-controlled, multi-center, dose-finding study to evaluate safety, tolerability and pharmacokinetics of sisunatovir in pediatric participants up to age 60 months with Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) - C5241009
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Participants 1 day to =60 months of age and weight =2.5 kg to =23 kg, A positive RSV diagnostic test with result available in source document to confirm eligibility either according to routine site practice or Investigator sites may use RSV POC test kits that are provided for this study. RSV diagnostic test, antigen or molecular test is acceptable, and should be collected within 48 hours of randomization. Note: Participants =30 days old with RSV diagnostic test collected within 72 hours is acceptable for eligibility., Evidence of LRTI by the presence of =1 from any of the following 4 categories (a through d): a.Increased respiratory rate for age: •<2 months: =60 bpm •=2 to <12 months: =50 bpm •=12 to =60 months: =40 bpm b.SpO2 < 95% on room air c.Increased respiratory effort as evidenced by =1 of the following: •Grunting with expiration •Nasal flaring •Retractions d.One or more of the following exam findings on auscultation: •Wheezing •Rhonchi •Rales or crackles, For participants >30 days old, RSV-related signs and/or symptoms must be present for =5 days at time of randomization. For participants 1 day to 30 days old, RSV related signs and/or symptoms must be present within =7 days at time of randomization.
排除标准
- •1.Any medical, developmental, or behavioral condition (including history of self-harmful behaviors) or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study., 2.Premature infants (gestational age less than 35 weeks) AND <1 year of post-natal age. Note: Infants 35- and 36-week gestational age are permitted if they weigh at least 2.5 kg and are at least 2 months post-natal age., 3.Neonates (1 to 30 days old) with intrauterine growth restriction defined by having 3 or more of the following: •Birth weight <10th percentile on population-based or customized growth charts •Head circumference <10th percentile •Length <10th percentile •Prenatal diagnosis of fetal growth restriction •Maternal pregnancy information associated with fetal growth restriction (eg, hypertension, pre-eclampsia), 4.Any clinically significant ECG abnormality in a participant's medical history, or in the pre-dose ECG that per investigator judgement may affect participant safety or interpretation of study results. Note: If sinus tachycardia is present, and not worse than expected due to underlying disease, participant may be considered if it does not interfere with evaluation of response to study intervention, at investigator discretion., 5.Participant history or risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, hypokalemia, hypomagnesaemia, congenital long QT syndrome) or congenital deafness. Family history of long QT syndrome or sudden unexplained death., 6.Known history of hepatic disease, concern for active acute or chronic viral hepatitis, or acute hepatic failure., 7.Participants >30 days only: Known history of AST, ALT or T bili abnormalities >2 x ULN within 6 months of screening. Laboratory assessments not required at screening for participants >30 days unless deemed necessary by the investigator to confirm normal hepatic function., 8.History of epilepsy or seizures. Participants with a history of febrile seizures will be permitted to enroll., 9.Expected to receive an antiviral for another viral infection (eg, influenza or COVID-19) within 10 days of screening., 10.Suspected or confirmed clinically significant moderate or severe bacterial infection (eg, bacterial pneumonia, bacteremia), that may interfere with the evaluation of response to the study intervention at investigator discretion. Participants with mild, localized infections such as otitis media or UTI can be included., 11.Evidence of severe respiratory failure requiring invasive mechanical ventilation or ECMO. Note: Participants requiring non-invasive ventilation, including high flow nasal cannula (HFNC), remain eligible for the study, 12.Known to have significant comorbidities, including genetic disorders (eg, trisomy 21); cardiopulmonary diseases (eg, hemodynamically significant congenital heart disease); significant pulmonary disease (eg, bronchopulmonary dysplasia, cystic fibrosis); history of renal failure including renal anomalies likely to be associated with renal insufficiency (eg, renal dysplasia, polycystic renal disease, renal agenesis); history of surgery for diaphragmatic hernia; any hereditary or acquired metabolic diseases, hematological or other malignancy; or is known to be HIV positive; or has evidence of severe neurologic impairment or developmental delay that would limit the ability to administer IMP or evaluate the safety or
研究者
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