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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01050257

Purpose

This 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, 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.

Condition	Intervention	Phase
Influenza	Drug: Tamiflu	Phase 3

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 Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Oseltamivir Oseltamivir Phosphate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Safety: AEs, vital signs, electrocardiograms, laboratory parameters [ Time Frame: AEs, vital signs: throughout study; electrocardiograms: days 1, 3, end of study; laboratory parameters: days 1, 3, after last intravenous infusion, end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Days 1, 3 ] [ Designated as safety issue: No ]
Viral load and shedding [ Time Frame: Days 1, 4, 6, 11 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2010
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Tamiflu 100 mg iv q12h for 5 days
Active Comparator: 2	Drug: Tamiflu 200 mg iv q12h for 5 days

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult and adolescent patients, 13 years of age and older
Diagnosis of influenza
</=96 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 10-50 mL/min

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050257

Contacts

Contact: Please reference Study ID Number: NV25118

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 100 Study Locations

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:	NCT01050257 History of Changes
Other Study ID Numbers:	NV25118
Study First Received:	January 14, 2010
Last Updated:	May 21, 2012
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 May 23, 2012