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临床试验/ACTRN12609000708257
ACTRN12609000708257终止2 期

A Randomized Open Label Study Comparing the Efficacy, Safety and Tolerability of Oral Administration of Amantadine and Ribavirin and Oseltamivir Versus Oseltamivir to Influenza A Virus Infected Immunocompromised Subjects.

Adamas Pharmaceuticals, Inc0 个研究点目标入组 125 人开始时间: 2009年8月17日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
125

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment

入排标准

年龄范围
1 Years 至 65 Years(—)
性别
All

入选标准

  • Immunocompromised as defined by one of either: recent solid organ or hematopoietic cell transplantation, chronic Graft Versus Host Disease (GVHD) requiring systemic immunosuppression, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose corticosteroids or Human Immunodeficiency Virus (HIV) positive.
  • Clinical diagnosis of Influenza A infection (mild.moderate or severe)
  • Onset of illness no more than 3 days prior to study entry.
  • Subjects (Male and Female) agree to use contraception through 24 weeks after last dose.

排除标准

  • Use of more than 2 doses of antiviral influenza medications since onset of symptoms
  • Critically ill
  • Creatinine Clearance less than 30 mL/min
  • Known genetic hemoglobinopathy
  • Presence of suspected or diagnosed non influenza infection requiring treatment.
  • Pschyatric or cognitive illness or recreational drug/alcohol use that would affect patient safety and compliance.
  • Documented non-influenza viral infection, including respiratory syncytial virus or Influenza B
  • Women who are pregnant, who are attempting to become pregnant, or who are breast-feeding.

研究者

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