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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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#216 - Blacktown
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#207 - Burwood
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#214 - Carlton
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#208 - Darlinghurst
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#205 - Glebe
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#201 - Maroubra
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#218 - Neutral Bay
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#202 - Sydney
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#204 - Sydney
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#219 - Biggera Waters
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#215 - Caboolture
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#221 - Deception Bay
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#217 - Jimboomba
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#220 - Nerang
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#206 - Sherwood
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#223 - Mirrabooka
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#222 - Morley
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#224 - Spearwood
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- Blacktown
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- Burwood
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- Carlton
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- Darlinghurst
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- Glebe
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- Maroubra
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- Sydney
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- Deception Bay
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- Jimboomba
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- Nerang
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- Sherwood
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- Mirrabooka
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- Morley
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- Spearwood
Recruitment outside Australia
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Somerset West
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Soweto

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

Ethics approval
Ethics application status

Summary
Brief summary
This is 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.
Trial website
https://clinicaltrials.gov/show/NCT01068912
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

Summary results
Other publications