EUCTR2015-004276-29-DK进行中（未招募）1 期
A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled,Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 inAdults who are Hospitalized with Influenza Caused by Type A Strains
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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. Age 18 years or older at the time of screening.
- •2. Written informed consent and any locally required authorization
- •obtained from the subject/legal representative prior to performing any
- •protocol-related procedures, including screening evaluations.
- •3. Females of childbearing potential who are sexually active with a
- •nonsterilized male partner must have evidence of not being pregnant
- •upon enrollment and have a negative pregnancy test prior to
- •administration of investigational product.
- •4. Hospitalized = 72 hours prior to receipt of a positive diagnostic test
- •for influenza A; confirmed with positive rapid antigen test, or confirmed
- •with culture, polymerase chain reaction, or antigen testing at the study
- •5. Onset of influenza symptoms = 144 hours (= 6 days) prior to
- •randomization.
- •6. Receiving supplemental oxygen.
- •7. Expected to participate in the study through Day 60.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Any condition that, in the opinion of the investigator, would interfere
- •with evaluation of study drugs or interpretation of subject safety or
- •study results.
- •2. Concurrent enrollment in another clinical study involving an
- •investigational treatment.
- •3. Hospitalized > 72 hours (> 3 days) prior to receipt of a positive
- •diagnostic test for influenza A.
- •4. Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor.
- •5. Receipt of any investigational antiviral medications within 30 days
- •prior to study drug dosing.
- •6. Previous receipt of an influenza mAb within past 100 days.
- •7. Pregnant or nursing female.
- •8. History of allergic disease or reactions likely to be exacerbated by any
- •components of the study drugs (MEDI8852 or oseltamivir).
- •9. Diagnosis of influenza B infection within 14 days prior to
- •randomization.
- •10. Employees of the sponsor, clinical study site, or any other individuals
- •involved with the conduct of the study, or immediate family members of
- •such individuals.
研究者
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