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A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza

This study has been terminated.
(The study was terminated prematurely after three influenza seasons.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01053663
First received: January 20, 2010
Last updated: June 16, 2016
Last verified: June 2016
Results First Received: January 15, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Influenza
Intervention: Drug: Tamiflu

  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
A total of 2428 participants were prescreened; of which, 2419 failed the prescreening evaluation. The most common reasons for failing the prescreening evaluation included the following: negative influenza diagnosis, not meeting the age criterion, ability to tolerate/absorb oral medication, and inability to comply with the study procedures.

Reporting Groups
  Description
Oseltamivir - All Participants Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.

Participant Flow:   Overall Study
    Oseltamivir - All Participants  
STARTED     9  
COMPLETED     3  
NOT COMPLETED     6  
Death                 2  
Lost to Follow-up                 1  
Poor IV Access                 1  
Transferred to Another Hospital                 1  
Negative Influenza Diagnosis                 1  



  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.
All-participants population included all participants who were enrolled in the study.

Reporting Groups
  Description
Oseltamivir: Age 91 to < 365 Days Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Oseltamivir: Age 31 to 90 Days Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Oseltamivir: Age 0 to 30 Days Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
Total Total of all reporting groups

Baseline Measures
    Oseltamivir: Age 91 to < 365 Days     Oseltamivir: Age 31 to 90 Days     Oseltamivir: Age 0 to 30 Days     Total  
Number of Participants  
[units: participants]
  7     1     1     9  
Age  
[units: days]
Mean (Standard Deviation)
  175.0  (62.0)     41.0     23.0     143.2  (82.9)  
Gender  
[units: participants]
       
Female     2     0     0     2  
Male     5     1     1     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Plasma Concentration (AUClast) of Oseltamivir and Oseltamivir Carboxylate on Day 1   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 ]

2.  Primary:   AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 2   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2 ]

3.  Primary:   AUClast of Oseltamivir and Oseltamivir Carboxylate on Day 4   [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]

4.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Oseltamivir and Oseltamivir Carboxylate on Day 1   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 ]

5.  Primary:   Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 2   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 2 ]

6.  Primary:   Cmax of Oseltamivir and Oseltamivir Carboxylate on Day 4   [ Time Frame: Pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]

7.  Secondary:   Time to the Maximum Observed Plasma Concentration (Tmax) of Oseltamivir and Oseltamivir Carboxylate   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]

8.  Secondary:   Last Measurable Plasma Concentration (Clast) of Oseltamivir and Oseltamivir Carboxylate   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]

9.  Secondary:   Time of the Last Measurable Plasma Concentration (Tlast) of Oseltamivir and Oseltamivir Carboxylate   [ Time Frame: Pre-dose (Hour 0), 2, 3-4, 5-7, and 10-12 hours post-dose on Day 1 and Day 2, pre-dose (Hour 0), 2 and 4 hours post-dose on Day 4 ]

10.  Secondary:   Number of Participants With Greater Than or Equal to (≥) 5−Fold Change in Neuraminidase Inhibition (NAI) Assay 50 Percent (%) Inhibitory Concentration (IC50) Values   [ Time Frame: Baseline, Days 1, 3, 4, 6, 15 ]

11.  Secondary:   Number of Participants With Oseltamivir Resistance Mutation   [ Time Frame: Up to Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Low number of participants enrolled in the study at the time that the study was terminated limits conclusions that can be derived from the study data.


  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01053663     History of Changes
Other Study ID Numbers: NP25138
Study First Received: January 20, 2010
Results First Received: January 15, 2016
Last Updated: June 16, 2016
Health Authority: United States: Food and Drug Administration