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Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MDVI, LLC
ClinicalTrials.gov Identifier:
NCT01068912
First received: February 12, 2010
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: February 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Influenza
Interventions: Drug: Favipiravir
Drug: Placebo comparator

  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
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Reporting Groups
  Description
1: Low Dose Favipiravir Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
2: High Dose Favipiravir Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Placebo Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days

Participant Flow:   Overall Study
    1: Low Dose Favipiravir   2: High Dose Favipiravir   Placebo
STARTED   134   195   201 
COMPLETED   123   173   186 
NOT COMPLETED   11   22   15 
Adverse Event                2                3                2 
Withdrawal by Subject                5                6                6 
Lost to Follow-up                3                7                3 
Protocol Violation                0                2                0 
aggravation influenza                1                1                1 
other underlying illness                0                3                3 



  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.
The Safety Population, defined as all patients who received study drug, was used for demographic and baseline characteristics and safety analyses, unless otherwise indicated.

Reporting Groups
  Description
1: Low Dose Favipiravir Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
2: High Dose Favipiravir Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Placebo Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
Total Total of all reporting groups

Baseline Measures
   1: Low Dose Favipiravir   2: High Dose Favipiravir   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   189   197   518 
Age 
[Units: Years]
Mean (Full Range)
 42.2 
 (20 to 79) 
 42.6 
 (20 to 75) 
 42.7 
 (20 to 80) 
 42.5 
 (20 to 80) 
Gender 
[Units: Participants]
       
Female   73   102   109   284 
Male   59   87   88   234 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   3   7   4   14 
Black or African American   17   22   23   62 
Hispanic or Latino   15   25   29   69 
Mestizo   14   20   17   51 
Native Hawaiian or other Pacific Islander   2   2   1   5 
White   72   103   115   290 
Other   7   7   6   20 
More than one race, including Hispanic or Latino   0   3   2   5 
More than one race, excluding Hispanic or Latino   2   0   0   2 
Region of Enrollment 
[Units: Participants]
       
United States   85   120   128   333 
Peru   24   36   36   96 
Australia   7   9   8   24 
South Africa   8   10   8   26 
Chile   2   9   7   18 
New Zealand   6   5   10   21 
Rapid Antigen Test Result [1] 
[Units: Participants]
       
Type A Positive   77   113   124   314 
Type B positive   30   45   43   118 
Type A and B positive   6   5   2   13 
Influenza negative   19   26   28   73 
[1] Tested positive for influenza A or B by a commercially available rapid antigen test of the nasopharynx. A patient with a negative rapid antigen test result was enrolled if the sponsor and investigator agreed that there was a known influenza outbreak circulating in the community.
Virus type identification 
[Units: Participants]
       
A (H1N1) pdm   39   32   39   110 
A (H3N2)   29   67   66   162 
 20   23   20   63 
Other   1   0   0   1 
Neither   43   67   72   182 


  Outcome Measures

1.  Primary:   Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza   [ Time Frame: 22 weeks ]


  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
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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Carol Epstein, Chief Medical Officer
Organization: MediVector, Inc., managing member MDVI, LLC
phone: 617-439-4500
e-mail: cepstein@medivector.com



Responsible Party: MDVI, LLC
ClinicalTrials.gov Identifier: NCT01068912     History of Changes
Other Study ID Numbers: T705aUS204
Study First Received: February 12, 2010
Results First Received: February 11, 2014
Last Updated: October 20, 2015
Health Authority: United States: Food and Drug Administration