A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
NCT ID: NCT01050257
Last Updated: 2013-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2010-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oseltamivir (TAMIFLU®) 100 mg
Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
Oseltamivir IV
Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Oseltamivir Oral
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Oseltamivir (TAMIFLU®) 200 mg
Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
Oseltamivir IV
Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Oseltamivir Oral
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Oseltamivir Open Label
Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
Oseltamivir IV
Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Oseltamivir Oral
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Interventions
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Oseltamivir IV
Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol.
Oseltamivir Oral
Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Acute ischemia or significant arrhythmia
13 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Montgomery, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Duarte, California, United States
Los Angeles, California, United States
San Diego, California, United States
Wilmington, Delaware, United States
Melbourne, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Madisonville, Kentucky, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Saint Joseph, Missouri, United States
Butte, Montana, United States
Grand Island, Nebraska, United States
Holmdel, New Jersey, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
South Bronx, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Youngstown, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Charleston, West Virginia, United States
Odense C, , Denmark
Bron, , France
Garches, , France
La Tronche, , France
Paris, , France
Paris, , France
Paris, , France
Tours, , France
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Győr, , Hungary
Gyula, , Hungary
Kaposvár, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szolnok, , Hungary
Szombathely, , Hungary
Veszprém, , Hungary
Genova, , Italy
Milan, , Italy
Monza, , Italy
Pavia, , Italy
Roma, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Bialystok, , Poland
Chorzów, , Poland
Radom, , Poland
Warsaw, , Poland
Bucharest, , Romania
Constanța, , Romania
Craiova, , Romania
Timișoara, , Romania
Elche, Alicante, Spain
Almería, Almeria, Spain
Madrid, Madrid, Spain
Countries
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Other Identifiers
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NV25118
Identifier Type: -
Identifier Source: org_study_id