A Multicenter, Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged =13 Years

F. Hoffmann-La Roche Ltd0 个研究点目标入组 200 人开始时间: 2010年8月6日最近更新: 2012年10月29日

适应症

试验速览

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•Male and female adults and adolescents, 13 years of age and older
•Diagnosis of influenza by virology testing or clinical diagnosis based on symptoms suggestive of influenza
•Less than or equal to 144 hours between the onset of influenza-like illness and first dose of study medication.
•Patient is willing and able to comply with study requirements and give consent, or, if applicable, consent may be given by a parent, legal guardian or legal representative.
•Patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus.
•Patients who are lactating may be enrolled only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 11
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 149
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Patients with clinical evidence of severe hepatic decompensation at the time of randomization (e.g., evidence of jaundice, ascites, hepatic encephalopathy, and coagulation disturbances—Child-Pugh score above 9).
•Electrocardiogram showing acute ischemia or significant arrhythmia
•Allergy to test medication
•Patients taking probenicid medication within 7 days before starting study medication
•Participation in a clinical trial or expanded access trial with an investigational drug in the 4 weeks prior to randomization (for renally impaired patients: 4 weeks prior to first dose of study medication).

发起方