A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01032837

Purpose

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients. The target sample size is 300-500 patients.

Condition	Intervention	Phase
Influenza	Drug: Oseltamivir	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Multicenter Trial of Oseltamivir [Tamiflu] Doses of 75 mg for 5 or 10 Days Versus 150 mg for 5 or 10 Days to Evaluate the Effect on the Duration of Viral Shedding in Influenza Patients With Pandemic (H1N1) 2009

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Oseltamivir Tamiflu

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Efficacy on the duration of viral shedding [ Time Frame: Day 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Viral load, development of oseltamivir resistance, time to resolution of influenza symptoms (assessment by patients), clinical course of the influenza [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety and tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessment day 11 ] [ Designated as safety issue: No ]

Enrollment:	102
Study Start Date:	November 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Oseltamivir 75 mg (adults) or weight-based unit dose (children) orally twice daily for 5 days Other Name: Tamiflu
Experimental: 2	Drug: Oseltamivir 75 mg (adults) or weight-base unit dose (children) orally twice daily for 10 days Other Name: Tamiflu
Experimental: 3	Drug: Oseltamivir 150 mg (adults) or twice weight-based unit dose (children) orally twice daily for 5 days Other Name: Tamiflu
Experimental: 4	Drug: Oseltamivir 150 mg (adults) or twice weight-based unit dose (children) orally twice daily for 10 days Other Name: Tamiflu

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pediatric, adolescent and adult patients >/=1 year of age
Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
</=96 hours between onset of influenza-like illness and first dose of oseltamivir

Exclusion Criteria:

Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
History of chronic renal failure or clinical suspicion of renal failure at baseline
Clinical evidence of hepatic compensation at the time of randomization
Known HIV infection
Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032837

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01032837 History of Changes
Other Study ID Numbers:	NV22155
Study First Received:	December 10, 2009
Last Updated:	November 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir

Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012