Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: May 19, 2014
Last verified: May 2014
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
  Hide Participant Flow

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
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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  
Virus type identification  
[units: participants]
       
A (H1N1) pdm     39     32     39     110  
A (H3N2)     29     67     66     162  
B     20     23     20     63  
Other     1     0     0     1  
Neither     43     67     72     182  
[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.



  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
  Hide 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.


  More Information
  Hide More Information

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


No publications provided


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: May 19, 2014
Health Authority: United States: Food and Drug Administration