A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	3/30/2013
Start Date:	January 2011
End Date:	January 2013
Contact:	Please reference Study ID Number: NP25138 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

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

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.

Inclusion Criteria:

- Infant patients

- Date of birth to date of enrollment is <1 year

- Diagnosis of influenza

- Duration of influenza symptoms
- - Parent/guardian willing to have patient receive intravenous therapy for 3 or 4 days
(5 or 6 doses of study drug)

Exclusion Criteria:

- Date of conception to date of birth + date of birth to enrollment is <36 weeks

- Creatinine clearance <30 mL/min/1.73m2

- Patients receiving any form of renal replacement therapy at baseline

- Clinical evidence of severe hepatic decompensation at the time of enrollment

- Patients taking probenecid medication within 1 week prior to study day 1 or during
the study

We found this trial at

sites

Clinical Trial Facility in Ann Arbor Michigan

Ann Arbor, Michigan 48109

from

Ann Arbor, MI