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

Phase 1

• Conditions: Treatment of Influenza [seasonal or pandemic (H1N1) 2009]; MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza; MedDRA version: 12.1Level: LLTClassification code 10022001Term: Influenza (epidemic); MedDRA version: 12.1Level: LLTClassification code 10022002Term: Influenza A virus infection; MedDRA version: 12.1Level: LLTClassification code 10022003Term: Influenza B virus infection

• Registration Number: EUCTR2010-020083-38-FR
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-17
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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 96 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
• Female patients who are pregnant may be enrolled only if the potential benefit justifies the potential risk to the fetus
• Female 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients with clinical evidence of severe hepatic decompensation at the time of randomization
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified