This trial is active, not recruiting.

Condition influenza
Treatment tamiflu
Phase phase 1
Sponsor Hoffmann-La Roche
Start date January 2011
End date May 2013
Trial size 7 participants
Trial identifier NCT01053663, NP25138


This open-label study will assess the pharmacokinetics and safety of oseltamivir [Tamiflu] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir [Tamiflu] therapy over 5 or 6 days. Optional oral therapy with oseltamivir [Tamiflu] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is <50 patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
10 doses over 5 or 6 days of which the first 5 or 6 doses must be intravenous, up to 5 days (10 doses) of additional intravenously or oral treatment if virus shedding continues at day 6

Primary Outcomes

Steady-state pharmacokinetics parameters AUC0-12 and Cmax of oseltamivir and oseltamivir carboxylate
time frame: Multiple sampling day 3 or 4
Safety Profile: AEs, vital signs, laboratory parameters
time frame: Days 1-11 and on follow up days 15 and 30

Secondary Outcomes

Viral load and shedding
time frame: Assessment days 1, 3 or 4, 6, 11, and optional at days 15 and 30
Development of resistance to oseltamivir
time frame: Assessment days 1, 3 or 4, 6, 11, and at days 15 and 30 if samples are collected

Eligibility Criteria

Male or female participants up to 365 days old.

Inclusion Criteria: - Infant patients - Date of birth to date of enrollment is <1 year - Diagnosis of influenza - Duration of influenza symptoms

Additional Information

Official title An Open-label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Oseltamivir in the Treatment of Infants Less Than One Year of Age With Influenza Infection
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.