Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 3:56 AM
Study NCT ID:
NCT00949533
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2009-07-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: