Trial record 1 of 1 for:    NCT01050257
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A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01050257
First received: January 14, 2010
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Influenza
Drug: Oseltamivir IV
Drug: Oseltamivir Oral
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:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]

    Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    On treatment = AEs that started between the day of first dose and within 2 days after the last dose. Off treatment = AEs that started more than 2 days after the last dose of study drug.



Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Days 1, 3 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Viral Shedding by Culture or RT-PCR [ Time Frame: Days 1, 4, 6, 11, 15 and 30 ] [ Designated as safety issue: No ]
    Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture [log10 median tissue culture infective dose (TCID50) > 0.5) or detection by RT-PCR (log 10 copies/mL).

  • Percentage of Participants With Viral Shedding by Culture [ Time Frame: Days 1, 4, 6, 11, 15, 30 ] [ Designated as safety issue: No ]
    Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by a positive culture=log10 median tissue culture infective dose (TCID50) > 0.5.

  • Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: Days 1, 4, 6, 11, 15 and 30 ] [ Designated as safety issue: No ]
    Nasal and throat swabs were collected on Days 1, 4, 6, 11, 15, and 30 and were sent to a central laboratory for analysis. The presence of viral shedding was determined by detection by RT-PCR (log 10 copies/mL).

  • Change From Baseline in Influenza Titer by Culture at Day 4 [ Time Frame: Baseline, Day 4 ] [ Designated as safety issue: No ]
    Nasal and throat swabs collected at Baseline and Day 4 were sent to a laboratory for analysis. Viral influenza titer (amount of virus present) was determined by culture. A log 10 median tissue culture infective dose (TCID50) > 0.5= Positive culture. A negative change from Baseline indicated improvement (less virus present).

  • Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4 [ Time Frame: Baseline, Day 4 ] [ Designated as safety issue: No ]
    Nasal and throat swabs were collected at Baseline and Day 4 and were sent to a central laboratory for analysis. Influenza Viral titers (amount of virus present) were determined by RT-PCR for Flu A and Flu B and were reported in log 10 copies/milliliter (mL). A negative change from Baseline indicated improvement (less virus present).

  • Percentage of Participants Who Had a Fever During the Study [ Time Frame: Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108 ] [ Designated as safety issue: No ]
    Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).

  • Time to Resolution of Fever for Participants Who Had a Fever at Baseline [ Time Frame: Baseline, Up to 30 Days ] [ Designated as safety issue: No ]
    Fever was defined as a temperature of ≥ 37.8 C (degrees Celsius). Resolution of fever was a temperature ≤ 37.2 for at least 21.5 hours.

  • Number of Participants With Viral Resistance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Nasal and Throat swabs were collected on Days 1, 4, 6, 11, 15 and 30 and were sent to a central laboratory for testing. Viral resistance was determined by phenotypic and genotypic testing.

  • Percentage of Participants With Influenza Symptoms [ Time Frame: Days 1, 11, 15, 30 ] [ Designated as safety issue: No ]
    Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.


Enrollment: 118
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: TAMIFLU®
Drug: 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 Name: TAMIFLU®
Experimental: 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.
Drug: 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.
Other Name: TAMIFLU®
Drug: 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 Name: TAMIFLU®
Experimental: 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.
Drug: 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.
Other Name: TAMIFLU®
Drug: 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 Name: TAMIFLU®

  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
  • ≤ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
Montgomery, Alabama, United States, 36106
United States, Arizona
Phoenix, Arizona, United States, 85008
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Duarte, California, United States, 91010
Los Angeles, California, United States, 90027
San Diego, California, United States, 92120
United States, Delaware
Wilmington, Delaware, United States, 19803
United States, Florida
Melbourne, Florida, United States, 32901
Miami, Florida, United States, 33126
Pensacola, Florida, United States, 32504
South Miami, Florida, United States, 33143
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Maywood, Illinois, United States, 60153
United States, Iowa
Des Moines, Iowa, United States, 50314
United States, Kansas
Kansas City, Kansas, United States, 64128
Overland Park, Kansas, United States, 66211
Wichita, Kansas, United States, 67214
United States, Kentucky
Madisonville, Kentucky, United States, 42431
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
Detroit, Michigan, United States, 48202
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Duluth, Minnesota, United States, 55805
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Joseph, Missouri, United States, 64506
United States, Montana
Butte, Montana, United States, 59701
United States, Nebraska
Grand Island, Nebraska, United States, 68803
United States, New Jersey
Holmdel, New Jersey, United States, 07733
United States, New York
Bronx, New York, United States, 10467
New York, New York, United States, 10032
New York, New York, United States, 10007
New York, New York, United States, 10065
South Bronx, New York, United States, 10461
Stony Brook, New York, United States, 11794
United States, North Carolina
Charlotte, North Carolina, United States, 28233
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Akron, Ohio, United States, 44304
Cincinnati, Ohio, United States, 45229
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44109
Dayton, Ohio, United States, 45404
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Pittsburgh, Pennsylvania, United States, 15213-2582
United States, Texas
Dallas, Texas, United States, 75216
Dallas, Texas, United States, 75235
San Antonio, Texas, United States, 78205
San Antonio, Texas, United States, 78232
United States, Virginia
Norfolk, Virginia, United States, 23510
United States, West Virginia
Charleston, West Virginia, United States, 25304
Denmark
Odense C, Denmark, 5000
France
Bron, France, 69677
Garches, France, 92380
La Tronche, France, 38700
Paris, France, 75970
Paris, France, 75679
Paris, France, 75651
Tours, France, 37044
Hungary
Budapest, Hungary, 1097
Budapest, Hungary, 1125
Debrecen, Hungary, 4012
Eger, Hungary, 3300
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kaposvar, Hungary, 7400
Miskolc, Hungary, 3526
Nyiregyhaza, Hungary, 4400
Pecs, Hungary, 7624
Szeged, Hungary, 6725
Szolnok, Hungary, 5000
Szombathely, Hungary, 9700
Veszprem, Hungary, H-8200
Italy
Genova, Italy, 16132
Milano, Italy, 20157
Monza, Italy, 20052
Pavia, Italy, 27100
Roma, Italy, 00149
Lithuania
Kaunas, Lithuania, 47116
Vilnius, Lithuania, 08117
Poland
Bialystok, Poland, 15-540
Chorzow, Poland, 41-500
Radom, Poland, 26-610
Warszawa, Poland, 01-201
Romania
Bucharest, Romania, 21105
Constanta, Romania, 8700
Craiova, Romania, 200515
Timisoara, Romania, 300310
Spain
Elche, Alicante, Spain, 03203
Almeria, Spain, 04009
Madrid, Spain, 28905
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01050257     History of Changes
Other Study ID Numbers: NV25118
Study First Received: January 14, 2010
Results First Received: August 28, 2013
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases
Oseltamivir
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014