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临床试验/EUCTR2016-001008-49-Outside-EU/EEA
EUCTR2016-001008-49-Outside-EU/EEA进行中(未招募)1 期

A randomized, multicenter trial of oseltamivir doses of 75 mg for 5 or 10 days versus 150 mg for 5 or 10 days in influenza patients with pandemic (H1N1) 2009

F. Hoffmann-La Roche AG0 个研究点目标入组 400 人开始时间: 2016年9月30日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
400

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

  • - Pediatric, adolescent and adult patients >/=1 year of age
  • - Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
  • - Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
  • - Are the trial subjects under 18? yes
  • Number of subjects for this age range: 200
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • - Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
  • - History of chronic renal failure or clinical suspicion of renal failure at baseline
  • - Clinical evidence of hepatic compensation at the time of randomization
  • - Known HIV infection
  • - Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

研究者

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