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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Oseltamivir IV (Drug); Oseltamivir Oral (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche


This partially 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 of a further 5 days, 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death

Secondary outcome:


Percentage of Participants With Viral Shedding by Culture or RT-PCR

Percentage of Participants With Viral Shedding by Culture

Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Change From Baseline in Influenza Titer by Culture at Day 4

Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4

Percentage of Participants Who Had a Fever During the Study

Time to Resolution of Fever for Participants Who Had a Fever at Baseline

Number of Participants With Viral Resistance

Percentage of Participants With Influenza Symptoms


Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Adult and adolescent patients, 13 years of age and older

- Diagnosis of influenza

- ≤ 144 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 10-60 mL/min Exclusion Criteria:

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

- Acute ischemia or significant arrhythmia

Locations and Contacts

Odense C 5000, Denmark

Bron 69677, France

Garches 92380, France

La Tronche 38700, France

Paris 75651, France

Paris 75679, France

Paris 75970, France

Tours 37044, France

Budapest 1097, Hungary

Budapest 1125, Hungary

Debrecen 4012, Hungary

Eger 3300, Hungary

Gyor 9024, Hungary

Gyula 5700, Hungary

Kaposvar 7400, Hungary

Miskolc 3526, Hungary

Nyiregyhaza 4400, Hungary

Pecs 7624, Hungary

Szeged 6725, Hungary

Szolnok 5000, Hungary

Szombathely 9700, Hungary

Veszprem H-8200, Hungary

Genova 16132, Italy

Milano 20157, Italy

Monza 20052, Italy

Pavia 27100, Italy

Roma 00149, Italy

Kaunas 47116, Lithuania

Vilnius 08117, Lithuania

Bialystok 15-540, Poland

Chorzow 41-500, Poland

Radom 26-610, Poland

Warszawa 01-201, Poland

Bucharest 21105, Romania

Constanta 8700, Romania

Craiova 200515, Romania

Timisoara 300310, Romania

Almeria 04009, Spain

Madrid 28905, Spain

Birmingham, Alabama 35233, United States

Montgomery, Alabama 36106, United States

Elche, Alicante 03203, Spain

Phoenix, Arizona 85008, United States

Little Rock, Arkansas 72205, United States

Duarte, California 91010, United States

Los Angeles, California 90027, United States

San Diego, California 92120, United States

Wilmington, Delaware 19803, United States

Melbourne, Florida 32901, United States

Miami, Florida 33126, United States

Pensacola, Florida 32504, United States

South Miami, Florida 33143, United States

Tampa, Florida 33606, United States

Atlanta, Georgia 30309, United States

Chicago, Illinois 60612, United States

Chicago, Illinois 60637, United States

Maywood, Illinois 60153, United States

Des Moines, Iowa 50314, United States

Kansas City, Kansas 64128, United States

Overland Park, Kansas 66211, United States

Wichita, Kansas 67214, United States

Madisonville, Kentucky 42431, United States

New Orleans, Louisiana 70121, United States

Worcester, Massachusetts 01655, United States

Detroit, Michigan 48202, United States

Kalamazoo, Michigan 49007, United States

Duluth, Minnesota 55805, United States

Minneapolis, Minnesota 55454, United States

Jackson, Mississippi 39202, United States

St. Joseph, Missouri 64506, United States

Butte, Montana 59701, United States

Grand Island, Nebraska 68803, United States

Holmdel, New Jersey 07733, United States

Bronx, New York 10467, United States

New York, New York 10007, United States

New York, New York 10032, United States

New York, New York 10065, United States

South Bronx, New York 10461, United States

Stony Brook, New York 11794, United States

Charlotte, North Carolina 28233, United States

Winston-Salem, North Carolina 27103, United States

Akron, Ohio 44304, United States

Cincinnati, Ohio 45229, United States

Cincinnati, Ohio 45267, United States

Cleveland, Ohio 44109, United States

Dayton, Ohio 45404, United States

Youngstown, Ohio 44501, United States

Oklahoma City, Oklahoma 73104, United States

Philadelphia, Pennsylvania 19106, United States

Pittsburgh, Pennsylvania 15213-2582, United States

Dallas, Texas 75216, United States

Dallas, Texas 75235, United States

San Antonio, Texas 78205, United States

San Antonio, Texas 78232, United States

Norfolk, Virginia 23510, United States

Charleston, West Virginia 25304, United States

Additional Information

Starting date: January 2010
Last updated: August 28, 2013

Page last updated: August 23, 2015

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