EUCTR2020-001966-13-PL进行中（未招募）1 期
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 36 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) - RSVPEDs
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •1. Male or female who is either:
- •born =37 weeks of gestation and is age =28 days to =36months, defined at the time of randomization, or
- •born <37 weeks of gestation and is age =6 months to =36 months, defined at the time of randomization
- •2. Subjects diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection by another respiratory pathogen (respiratory virus, fungus, or bacteria), except in cases where the Investigator assesses that a co-detection of the following viruses is not contributing to the patient's disease: human bocavirus, rhinovirus, or rhinovirus/enterovirus;
- •3. Subjects with signs of an acute respiratory illness (eg, fever [or symptoms of fever], cough, nasal congestion, runny nose, rapid breathing, shortness of breath, or wheezing) with onset =7 days before the time of signing the informed consent form (ICF)
- •Note: Time of onset of symptoms is defined from the caregiver(s) estimated time of awareness of the first sign of respiratory infection
- •4. Have a calculated creatinine clearance rate not below the lower limit of normal (LLN) for the subject’s age as determined by the Schwartz equation (Schwartz & Work, 2009) at Screening
- •5. In the Investigator’s opinion, the subject’s caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned
- •Additional inclusion criterion for Part 1 Cohort 1
- •6. Subject is currently or is planned to be hospitalized as a consequence of RSV infection and is not anticipated to be discharged in less than 24 hours after enrollment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •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. Use of or anticipated need for intensive monitoring and associated medical care, eg admission to ICU or equivalent medical setting, requirement for mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness
- •2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
- •3. Subjects who are considered unable to take study drug orally, eg, as a consequence of acute respiratory distress, or unable to absorb study drug enterally
- •4. Subjects who have received blood products within 6 months of study drug administration
- •5. Height or weight outside of the 5th to 95th percentile for the respective ages, at the time of enrollment
- •6. Subjects with underlying immune deficiency, eg, from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency
- •7. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening)
- •8. Subjects who have had major surgery in the 6 weeks before randomization
- •9. Subject receiving chronic oxygen therapy at home before admission
- •10. Subjects who are being breastfed by a mother taking any of the excluded medications
- •11. Subjects whose mother received an investigational RSV vaccination while pregnant with the subject
- •12. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening
- •13. Subjects who received systemic medications (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies
- •14. Subjects who are receiving an investigational or approved medication that is intended to prevent or treat RSV infection (eg, ribavirin or palivizumab or other RSV specific monoclonal antibody) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug, and/or is currently enrolled in a clinical trial of such a medication
- •15. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug
- •16. Subjects who are enrolled in another investigational drug or vaccine study
- •17. Known allergy/hypersensitivity or intolerance to EDP-938 placebo or their excipients
研究者
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