EUCTR2013-005104-33-GB进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized with Respiratory Syncytial Virus (RSV) Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 181
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
入选标准
- •1) Subject’s parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.
- •2) In the investigator’s opinion, the subject’s parent(s)/legal guardian(s) understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.
- •3) Male or female infant who
- •is = 1.0 to = 12.0 months of age (inclusive), defined at the time of hospital admission or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness
- •has been diagnosed with RSV infection based on study-supplied BINAX NOW RSV test or an RSV PCR or any other RSV assay conducted at the clinical trial site. NOTE: A subject remains eligible if any RSV result is positive. (RSV-specific PCR run locally is strongly encouraged, but not required.) Coinfection with other respiratory viruses or bacterial coinfection in addition to RSV is permissible.
- •has been hospitalized for < 96 hours (at the time of randomization) for confirmed RSV infection (NOTE: nosocomial RSV infection is excluded)
- •has had symptoms consistent with RSV infection (e.g., runny nose, cough, sneezing, fever, or tachypnea) for =5 days at the time of randomization (unless otherwise instructed by the IDMC which may modify the duration to up to 7 days)
- •4) With the exception of the RSV-related illness, the subject is in otherwise good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and ECG
- •5. Creatinine clearance is not below the lower limit of normal for the subject’s age (Schwartz equation calculation preferred, however alternative equations may be utilized to determine eligiblity if deemed acceptable by the Investigator and Medical Monitor).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 260
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of or concurrent clinically significant medical illness (not directly attributable to the acute RSV infection) – including, but not limited to cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, immunologic, musculoskeletal, oncologic, or congenital disorders – as judged by the Investigator. Specifically excluded conditions include but are not limited to:
- •a. Immunosuppressed state
- •b. Bronchopulmonary dysplasia
- •c. Congenital heart disease
- •d. Down’s syndrome
- •2) Prematurity, defined as gestational age < 37 weeks at birth
- •3) Subjects receiving invasive endotracheal mechanical ventilation
- •4) Subjects who are thought to have a poorly functioning gastrointestinal tract (i.e., unable to absorb drugs or nutrition via enteral route). NOTE: The use of intravenous fluids is not exclusionary so long as the investigator believes the patient’s gastrointestinal tract still functions properly (i.e., is able to absorb drugs or nutrition).
- •5) Subjects with clinically significant laboratory abnormalities which are deemed by the Investigator to represent a safety risk to participation in this study. Other laboratory parameters outside the reference range for the subject’s age may be included if the investigator considers the abnormalities unlikely to introduce additional risk factors and will not interfere with data interpretation. A single repeat laboratory evaluation (under appropriate conditions, e.g. not hemolyzed)is allowed for eligibility determination.
- •6) Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting the study requirements
- •7) Clinically significant abnormal ECG findings, as judged by the Investigator or qualified designee
- •8) Subjects anticipated to be discharged from the hospital in < 24 hours from the time of randomization
- •9) Exclusionary medications include:
- •a. Herbal supplements which have evidence of adversely affecting absorption and clearance mechanisms (e.g., strong inhibitors of OAT3) within 21 days prior to randomization
- •b. The following prescription medications:
- •? Use of systemic medications (either chronically (i.e., >14 days
- •for neonates and infants <2 months old, or >28 days for
- •subjects =2-=12 months of age) or within the 21 days prior to randomization) which are known to modulate the host immune response and/or increase viral shedding such as corticosteroids or other immunomodulatory therapies. The only exception is systemic corticosteroids will be acceptable if they are not taken chronically for a non-RSV-related indication.
- •? Prescription medications used within 14 days prior to randomization to treat the RSV infection itself (e.g., ribavirin, intravenous immunoglobulin). Prescription medications intended to treat the symptoms/sequelae of the RSV infection are permitted.
- •? Prescription medications which are known to be strong
- •inhibitors of the OAT3 transporter, within 21 days prior to
- •randomization
- •c. Investigational drug trial medications within 30 days or 5 half-lives (whichever is longer) prior to randomization
研究者
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