EUCTR2006-002468-24-BG进行中（未招募）1 期
A double-blind, randomized, stratified, multi-center trial evaluating conventional and double dose oseltamivir in the treatment of immunocompromised patients with influenza
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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
- •Age greater than or equal to 1 year
- •Rapid diagnostic test, PCR, or viral culture positive for influenza
- •Immunocompromised subject defined as one who meets any of the following:
- •- Primary immunodeficiency at risk for viral infections OR
- •- Secondary immunodeficiency
- •- SOT with ongoing immunosuppression OR
- •- Allogenic HSCT with ongoing immunosuppression
- •- HIV with CD4 count < 500/mm3 and, in the investigator's opinion, considered immunocompromised OR
- •- Hematologic malignancies OR
- •- Systemic (e.g. enteric, sc, im or iv)
- •immunosuppressive therapy, irrespective of medical indication, started at least 12 weeks prior to, and ongoing at the time of first dose of study drug
- •Symptoms suggestive of influenza like illness including, but not limited to fever, cough, or coryza
- •Use of an effective contraceptive, as specified by protocol; women of
- •childbearing potential cannot be pregnant or breastfeeding.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Influenza vaccination with live attenuated vaccine in the 2 weeks prior
- •to randomization
- •Antiviral treatment for influenza in 2 weeks prior to randomization
- •Severe hepatic impairment
- •Any current renal replacement therapy
- •Any gastrointestinal disorders which may intefere with the absorption
- •Participation in a study with an investigational drug from 4 weeks prior
- •to study start until study end
研究者
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