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
Results First Received: August 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: Oseltamivir IV
Drug: Oseltamivir Oral

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study included a 5 day treatment period and an optional extension. Participants were considered to have completed treatment if they completed the 5-day course of treatment (IV and/or oral).

Reporting Groups
  Description
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 (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 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.

Participant Flow:   Overall Study
    Oseltamivir (TAMIFLU®) 100 mg     Oseltamivir (TAMIFLU®) 200 mg     Oseltamivir Open Label  
STARTED     50     53     15  
Received Treatment     49     50     14  
Safety Population: Actual Dose Received     48     51 [1]   14  
Intent-to-treat Infected Confirmed     30     32     10  
Switched to Oral Treatment     28     31     3  
COMPLETED     39 [2]   40     8  
NOT COMPLETED     11     13     7  
Adverse Event                 4                 4                 2  
Admin/Other (did not switch to oral)                 6                 2                 2  
Withdrawal by Subject                 0                 3                 0  
No reason specified                 0                 0                 2  
Refused treatment/ Did not Cooperate                 1                 1                 0  
Violation criteria                 0                 1                 0  
Failure to return                 0                 2                 0  
Death                 0                 0                 1  
[1] One participant randomized to 100 mg actually received the 200 mg doses.
[2] Completed 5 days of treatment either IV or Oral



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Demographics are based on the all enrolled patients population.

Reporting Groups
  Description
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 (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 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.
Total Total of all reporting groups

Baseline Measures
    Oseltamivir (TAMIFLU®) 100 mg     Oseltamivir (TAMIFLU®) 200 mg     Oseltamivir Open Label     Total  
Number of Participants  
[units: participants]
  50     53     15     118  
Age  
[units: years]
Mean ± Standard Deviation
  44.8  ± 16.68     44.3  ± 18.09     66.9  ± 18.28     47.4  ± 18.93  
Gender  
[units: participants]
       
Female     25     27     8     60  
Male     25     26     7     58  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events(SAEs, AEs Leading to Withdrawal, and Death   [ Time Frame: Up to 30 days ]

2.  Secondary:   Percentage of Participants With Viral Shedding by Culture or RT-PCR   [ Time Frame: Days 1, 4, 6, 11, 15 and 30 ]

3.  Secondary:   Percentage of Participants With Viral Shedding by Culture   [ Time Frame: Days 1, 4, 6, 11, 15, 30 ]

4.  Secondary:   Percentage of Participants With Viral Shedding by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)   [ Time Frame: Days 1, 4, 6, 11, 15 and 30 ]

5.  Secondary:   Change From Baseline in Influenza Titer by Culture at Day 4   [ Time Frame: Baseline, Day 4 ]

6.  Secondary:   Change From Baseline in Influenza Titer by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 4   [ Time Frame: Baseline, Day 4 ]

7.  Secondary:   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 ]

8.  Secondary:   Time to Resolution of Fever for Participants Who Had a Fever at Baseline   [ Time Frame: Baseline, Up to 30 Days ]

9.  Secondary:   Number of Participants With Viral Resistance   [ Time Frame: 30 days ]

10.  Secondary:   Percentage of Participants With Influenza Symptoms   [ Time Frame: Days 1, 11, 15, 30 ]

11.  Secondary:   Pharmacokinetics   [ Time Frame: Days 1, 3 ]
Results not yet posted.   Anticipated Posting Date:   12/2013   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


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