EUCTR2016-004009-15-LV进行中（未招募）1 期
Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
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
- •Subjects meeting all of the following criteria are eligible to participate in this study:
- •1. Male and female subjects aged = 18 years. For a country where the legal age of consent is >18 years old, the country requirements should be followed.
- •2. Test positive for influenza A by rapid antigen test or with another commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions, or an acceptable local test including, PCR, FIA, or ELISA
- •3. Onset of influenza symptoms no more than 5 days before VIS410/placebo infusion; symptoms may include cough, dyspnea, sore throat, fever, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea, and vomiting.
- •4. Requirement for oxygen support including any positive pressure ventilation (PPV).
- •5. Women of childbearing potential must have a negative pregnancy test within 2 days prior to VIS410/placebo infusion.
- •6. Women should fulfill one of the following criteria:
- •a. Post-menopausal; either amenorrhea = 12 months or follicle stimulating hormone > 40 mIU/mL as documented in their medical history
- •b. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
- •c. Women of childbearing potential participating in heterosexual relations must be willing to use adequate contraception from screening until 60 days post VIS410/placebo infusion (see Section 6.2).
- •7. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method (see Section 6.2) when having heterosexual intercourse, from screening until 60 days post VIS410/placebo infusion.
- •8. Subject is able and willing to comply with study procedures, as per protocol.
- •9. Subject, or a legally authorized representative is able to understand the purpose and risks of the study and willing to give voluntary written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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 190
排除标准
- •Subjects meeting any of the following criteria are excluded from participation in this study:
- •1. Known or suspected intolerance or hypersensitivity to VIS410, oseltamivir, pretreatment medications (diphenhydramine, or to both ibuprofen and acetylsalicylic acid [ASA]), or closely related compounds (eg, other monoclonal antibodies).
- •2. Subjects who have received VIS410 in the past.
- •3. Subjects who have a history of receiving monoclonal antibody products within 3 months prior to VIS410/placebo dosing or planned administration of another monoclonal antibody during the study period.
- •4. Subjects who have taken more than 6 doses of an approved antiviral therapy for influenza within the prior 96 hours (eg, oral oseltamivir, inhaled zanamivir, IV peramivir, or oral ribavirin) between onset of symptoms and VIS410/placebo dosing.
- •5. Subjects with known co-infection with influenza B or other viral respiratory infections (eg, respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
- •6. Subjects with lung transplant or history of severe chronic lung disease, including cystic fibrosis or any condition requiring home oxygen therapy.
- •7. Subjects on extracorporeal membrane oxygenation at time of randomization.
- •8. Subjects with end-stage renal disease (ESRD) who are not undergoing hemodialysis.
- •9. Subjects with active graft-vs-host disease, hematopoietic stem cell transplant within the previous 90 days, or human immunodeficiency virus infection with a CD4 cell count of less than 200 per cubic millimeter.
- •10. High probability of mortality within 48 hours of randomization as determined by the Investigator.
- •11. Women who are pregnant, breast-feeding, or considering to become pregnant.
- •12. Subjects in whom nasopharyngeal swabbing is not possible.
- •13. Subjects weighing less than 45 kg.
- •14. Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer.
- •15. Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
- •16. Subjects unable to comply with study protocol procedures and study visit schedules for whatever reason.
- •17. Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator.
研究者
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