InfluenzaPhase 3NCT01050257
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
A Phase 3 study testing Oseltamivir IV and Oseltamivir Oral in people with Influenza, run by Hoffmann-La Roche at 96 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir IV and Oseltamivir Oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 96 sitesin 9 countries
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
Trial locations and contacts
96 sites in 9 countries.
96 sites in 9 countries
United States56 sites
Study site
Akron, Ohio, 44304
Study site
Atlanta, Georgia, 30309
Study site
Birmingham, Alabama, 35233
Study site
Butte, Montana, 59701
Study site
Charleston, West Virginia, 25304
Study site
Charlotte, North Carolina, 28233
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45229
Study site
Cincinnati, Ohio, 45267
Study site
Cleveland, Ohio, 44109
Study site
Dallas, Texas, 75216
Study site
Dallas, Texas, 75235
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Dayton, Ohio, 45404
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Des Moines, Iowa, 50314
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Detroit, Michigan, 48202
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Duarte, California, 91010
Study site
Duluth, Minnesota, 55805
Study site
Grand Island, Nebraska, 68803
Study site
Holmdel, New Jersey, 07733
Study site
Jackson, Mississippi, 39202
Study site
Kalamazoo, Michigan, 49007
Study site
Kansas City, Kansas, 64128
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90027
Study site
Madisonville, Kentucky, 42431
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Maywood, Illinois, 60153
Study site
Melbourne, Florida, 32901
Study site
Miami, Florida, 33126
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Minneapolis, Minnesota, 55454
Study site
Montgomery, Alabama, 36106
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10007
Study site
New York, New York, 10032
Study site
New York, New York, 10065
Study site
Norfolk, Virginia, 23510
Study site
Oklahoma City, Oklahoma, 73104
Study site
Overland Park, Kansas, 66211
Study site
Pensacola, Florida, 32504
Study site
Philadelphia, Pennsylvania, 19106
Study site
Phoenix, Arizona, 85008
Study site
Pittsburgh, Pennsylvania, 15213-2582
Study site
Saint Joseph, Missouri, 64506
Study site
San Antonio, Texas, 78205
Study site
San Antonio, Texas, 78232
Study site
San Diego, California, 92120
Study site
South Bronx, New York, 10461
Study site
South Miami, Florida, 33143
Study site
Stony Brook, New York, 11794
Study site
Tampa, Florida, 33606
Study site
The Bronx, New York, 10467
Study site
Wichita, Kansas, 67214
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Wilmington, Delaware, 19803
Study site
Winston-Salem, North Carolina, 27103
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Worcester, Massachusetts, 01655
Study site
Youngstown, Ohio, 44501
Hungary14 sites
Study site
Budapest, 1097
Study site
Budapest, 1125
Study site
Debrecen, 4012
Study site
Eger, 3300
Study site
Győr, 9024
Study site
Gyula, 5700
Study site
Kaposvár, 7400
Study site
Miskolc, 3526
Study site
Nyíregyháza, 4400
Study site
Pécs, 7624
Study site
Szeged, 6725
Study site
Szolnok, 5000
Study site
Szombathely, 9700
Study site
Veszprém, H-8200
France7 sites
Study site
Bron, 69677
Study site
Garches, 92380
Study site
La Tronche, 38700
Study site
Paris, 75651
Study site
Paris, 75679
Study site
Paris, 75970
Study site
Tours, 37044
Italy5 sites
Study site
Genova, 16132
Study site
Milan, 20157
Study site
Monza, 20052
Study site
Pavia, 27100
Study site
Roma, 00149
Poland4 sites
Study site
Bialystok, 15-540
Study site
Chorzów, 41-500
Study site
Radom, 26-610
Study site
Warsaw, 01-201
Romania4 sites
Study site
Bucharest, 21105
Study site
Constanța, 8700
Study site
Craiova, 200515
Study site
Timișoara, 300310
Spain3 sites
Study site
Almería, Almeria, 04009
Study site
Elche, Alicante, 03203
Study site
Madrid, Madrid, 28905
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Oseltamivir IV, Oseltamivir Oral
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir IVDrug
Also called TAMIFLU®
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 OralDrug
Also called TAMIFLU®
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.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir (TAMIFLU®) 100 mg | Experimental | 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. Receives: Drug: Oseltamivir IV; Drug: Oseltamivir Oral |
| Oseltamivir (TAMIFLU®) 200 mg | Experimental | 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. Receives: Drug: Oseltamivir IV; Drug: Oseltamivir Oral |
| Oseltamivir Open Label | Experimental | 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. Receives: Drug: Oseltamivir IV; Drug: Oseltamivir Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death
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.
Measured: Up to 30 days
Secondary outcomes (10)
Pharmacokinetics
Measured: Days 1, 3
Percentage of Participants With Viral Shedding by Culture or RT-PCR
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).
Measured: Days 1, 4, 6, 11, 15 and 30
Percentage of Participants With Viral Shedding by Culture
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.
Measured: Days 1, 4, 6, 11, 15, 30
Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
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).
Measured: Days 1, 4, 6, 11, 15 and 30
Change From Baseline in Influenza Titer by Culture at Day 4
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).
Measured: Baseline, Day 4
Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4
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).
Measured: Baseline, Day 4
Percentage of Participants Who Had a Fever During the Study
Fever was defined as a temperature of ≥ 37.8 C (degrees Celcius).
Measured: Baseline and Hours 12, 24, 36, 48, 60, 72, 84, 96 and 108
Time to Resolution of Fever for Participants Who Had a Fever at Baseline
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.
Measured: Baseline, Up to 30 Days
Number of Participants With Viral Resistance
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.
Measured: 30 days
Percentage of Participants With Influenza Symptoms
Influenza (flu) symptoms were nasal congestion, sore throat, cough, aches and pains, fatigue, headache or chills.
Measured: Days 1, 11, 15, 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050257
- Sponsor's protocol ID
- NV25118
- Status last verified
- Aug 2013
- First submitted
- 14 Jan 2010
- Last updated
- 1 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01050257
- Acronym / sponsor ID
- NV25118
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 1 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir (TAMIFLU®) 100 mg | Experimental | Drug: Oseltamivir IV, Drug: Oseltamivir OralOseltamivir (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 (TAMIFLU®) 200 mg | Experimental | Drug: Oseltamivir IV, Drug: Oseltamivir OralOseltamivir (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 Open Label | Experimental | Drug: Oseltamivir IV, Drug: Oseltamivir OralModerate/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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min
Key exclusion criteria (2 listed)
- Clinical evidence of severe hepatic decompensation at the time of randomization
- Acute ischemia or significant arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oseltamivir IVAlso: TAMIFLU®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. | Drug | Oseltamivir (TAMIFLU®) 100 mg, Oseltamivir (TAMIFLU®) 200 mg, Oseltamivir Open Label |
| Oseltamivir OralAlso: TAMIFLU®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. | Drug | Oseltamivir (TAMIFLU®) 100 mg, Oseltamivir (TAMIFLU®) 200 mg, Oseltamivir Open Label |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death
Time frame: Up to 30 days
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.
10 secondary outcomes
Pharmacokinetics
Time frame: Days 1, 3
Percentage of Participants With Viral Shedding by Culture or RT-PCR
Time frame: Days 1, 4, 6, 11, 15 and 30
Percentage of Participants With Viral Shedding by Culture
Time frame: Days 1, 4, 6, 11, 15, 30
Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Time frame: Days 1, 4, 6, 11, 15 and 30
Change From Baseline in Influenza Titer by Culture at Day 4
Time frame: Baseline, Day 4
Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4
Time frame: Baseline, Day 4
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
Time to Resolution of Fever for Participants Who Had a Fever at Baseline
Time frame: Baseline, Up to 30 Days
Number of Participants With Viral Resistance
Time frame: 30 days
Percentage of Participants With Influenza Symptoms
Time frame: Days 1, 11, 15, 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
96 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oseltamivir IV and Oseltamivir Oral in people with Influenza, run by Hoffmann-La Roche at 96 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States, Hungary, France, Italy, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.