A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

Roche

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Drug: Oseltamivir Oral; Drug: Oseltamivir IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01050257

NV25118

Details and patient eligibility

About

This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.

Enrollment: 118 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult and adolescent patients, 13 years of age and older
• Diagnosis of influenza
• ≤ 144 hours between the onset of influenza-like illness and first dose of study drug

Non-randomized, open-label treatment group:

• Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min

Exclusion criteria

• Clinical evidence of severe hepatic decompensation at the time of randomization
• Acute ischemia or significant arrhythmia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 3 patient groups

Oseltamivir (TAMIFLU®) 100 mg

Experimental group

Description:

Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Treatment:

Drug: Oseltamivir IV

Drug: Oseltamivir Oral

Oseltamivir (TAMIFLU®) 200 mg

Experimental group

Description:

Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.

Treatment:

Drug: Oseltamivir IV

Drug: Oseltamivir Oral

Oseltamivir Open Label

Experimental group

Description:

Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.

Treatment:

Drug: Oseltamivir IV

Drug: Oseltamivir Oral