Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01068912




Registration number
NCT01068912
Ethics application status
Date submitted
12/02/2010
Date registered
15/02/2010
Date last updated
18/11/2015

Titles & IDs
Public title
Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Favipiravir in Adult Patients With Uncomplicated Influenza
Secondary ID [1] 0 0
T705aUS204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Favipiravir
Treatment: Drugs - Favipiravir
Treatment: Drugs - Placebo comparator

Experimental: 1: Experimental - Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days

Experimental: 2: Experimental - High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days

Placebo comparator: Placebo - Placebo


Treatment: Drugs: Favipiravir
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days

Treatment: Drugs: Favipiravir
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days

Treatment: Drugs: Placebo comparator
Placebo BID x 1 day, and Placebo BID x 4 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
Timepoint [1] 0 0
22 weeks

Eligibility
Key inclusion criteria
1. Patients who test positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community.
2. Patients = 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients = 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken.
3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment:

* Cough
* Sore throat
* Headache
* Nasal congestion
* Feeling feverish
* Body aches and pains
* Fatigue (tiredness)
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed under the inclusion criteria) for 36 hours or more prior to study screening.
2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old tuberculosis).
3. Patients who at the beginning of the study are suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, etc.).
4. Patients who have serious chronic diseases. For example, patients with HIV, cancer (i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage), and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
#216 - Blacktown
Recruitment hospital [2] 0 0
#207 - Burwood
Recruitment hospital [3] 0 0
#214 - Carlton
Recruitment hospital [4] 0 0
#208 - Darlinghurst
Recruitment hospital [5] 0 0
#205 - Glebe
Recruitment hospital [6] 0 0
#201 - Maroubra
Recruitment hospital [7] 0 0
#218 - Neutral Bay
Recruitment hospital [8] 0 0
#202 - Sydney
Recruitment hospital [9] 0 0
#204 - Sydney
Recruitment hospital [10] 0 0
#219 - Biggera Waters
Recruitment hospital [11] 0 0
#215 - Caboolture
Recruitment hospital [12] 0 0
#221 - Deception Bay
Recruitment hospital [13] 0 0
#217 - Jimboomba
Recruitment hospital [14] 0 0
#220 - Nerang
Recruitment hospital [15] 0 0
#206 - Sherwood
Recruitment hospital [16] 0 0
#223 - Mirrabooka
Recruitment hospital [17] 0 0
#222 - Morley
Recruitment hospital [18] 0 0
#224 - Spearwood
Recruitment postcode(s) [1] 0 0
- Blacktown
Recruitment postcode(s) [2] 0 0
- Burwood
Recruitment postcode(s) [3] 0 0
- Carlton
Recruitment postcode(s) [4] 0 0
- Darlinghurst
Recruitment postcode(s) [5] 0 0
- Glebe
Recruitment postcode(s) [6] 0 0
- Maroubra
Recruitment postcode(s) [7] 0 0
- Neutral Bay
Recruitment postcode(s) [8] 0 0
- Sydney
Recruitment postcode(s) [9] 0 0
- Biggera Waters
Recruitment postcode(s) [10] 0 0
- Caboolture
Recruitment postcode(s) [11] 0 0
- Deception Bay
Recruitment postcode(s) [12] 0 0
- Jimboomba
Recruitment postcode(s) [13] 0 0
- Nerang
Recruitment postcode(s) [14] 0 0
- Sherwood
Recruitment postcode(s) [15] 0 0
- Mirrabooka
Recruitment postcode(s) [16] 0 0
- Morley
Recruitment postcode(s) [17] 0 0
- Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
Chile
State/province [35] 0 0
Antofagasta
Country [36] 0 0
Chile
State/province [36] 0 0
Curico
Country [37] 0 0
Chile
State/province [37] 0 0
Quillota
Country [38] 0 0
Chile
State/province [38] 0 0
Rancagua
Country [39] 0 0
Chile
State/province [39] 0 0
Santiago
Country [40] 0 0
Chile
State/province [40] 0 0
Talca
Country [41] 0 0
Chile
State/province [41] 0 0
Temuco
Country [42] 0 0
Chile
State/province [42] 0 0
Viña del Mar
Country [43] 0 0
New Zealand
State/province [43] 0 0
Auckland
Country [44] 0 0
New Zealand
State/province [44] 0 0
Bay of Plenty
Country [45] 0 0
New Zealand
State/province [45] 0 0
Canterbury
Country [46] 0 0
New Zealand
State/province [46] 0 0
Otago
Country [47] 0 0
New Zealand
State/province [47] 0 0
Hamilton
Country [48] 0 0
Paraguay
State/province [48] 0 0
Asuncion
Country [49] 0 0
Paraguay
State/province [49] 0 0
Asunción
Country [50] 0 0
Paraguay
State/province [50] 0 0
Luque
Country [51] 0 0
Peru
State/province [51] 0 0
Arequipa
Country [52] 0 0
Peru
State/province [52] 0 0
Callao
Country [53] 0 0
Peru
State/province [53] 0 0
Cusco
Country [54] 0 0
Peru
State/province [54] 0 0
ICA
Country [55] 0 0
Peru
State/province [55] 0 0
Lima
Country [56] 0 0
Peru
State/province [56] 0 0
Piura
Country [57] 0 0
Peru
State/province [57] 0 0
Trujillo
Country [58] 0 0
South Africa
State/province [58] 0 0
Benoni
Country [59] 0 0
South Africa
State/province [59] 0 0
Cape Town
Country [60] 0 0
South Africa
State/province [60] 0 0
Durban
Country [61] 0 0
South Africa
State/province [61] 0 0
Johannesburg
Country [62] 0 0
South Africa
State/province [62] 0 0
Kemptonpark
Country [63] 0 0
South Africa
State/province [63] 0 0
Kraaifontein
Country [64] 0 0
South Africa
State/province [64] 0 0
Krugersdorp
Country [65] 0 0
South Africa
State/province [65] 0 0
Port Elizabeth
Country [66] 0 0
South Africa
State/province [66] 0 0
Pretoria
Country [67] 0 0
South Africa
State/province [67] 0 0
Sandton
Country [68] 0 0
South Africa
State/province [68] 0 0
Somerset West
Country [69] 0 0
South Africa
State/province [69] 0 0
Soweto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MDVI, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Macy Guiont
Address 0 0
Syneos Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01068912