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

Influenza Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068912
• Other study ID #: T705aUS204
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2010
• Last updated: October 20, 2015
• Start date: February 2010
• Est. completion date: May 2012

Study information

• Verified date: October 2015
• Source: MDVI, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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)

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Favipiravir
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
• Favipiravir
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
• Placebo comparator
Placebo BID x 1 day, and Placebo BID x 4 days

Locations

Country	Name	City	State
Australia	#219	Biggera Waters	Queensland
Australia	#216	Blacktown	New South Wales
Australia	#207	Burwood	New South Wales
Australia	#215	Caboolture	Queensland
Australia	#214	Carlton	New South Wales
Australia	#208	Darlinghurst	New South Wales
Australia	#221	Deception Bay	Queensland
Australia	#205	Glebe	New South Wales
Australia	#217	Jimboomba	Queensland
Australia	#201	Maroubra	New South Wales
Australia	#223	Mirrabooka	Western Australia
Australia	#222	Morley	Western Australia
Australia	#220	Nerang	Queensland
Australia	#218	Neutral Bay	New South Wales
Australia	#206	Sherwood	Queensland
Australia	#224	Spearwood	Western Australia
Australia	#202	Sydney	New South Wales
Australia	#204	Sydney	New South Wales
Chile	#613	Antofagasta
Chile	#612	Curico
Chile	#606	Quillota
Chile	#614	Rancagua
Chile	#603	Santiago
Chile	#607	Santiago
Chile	#609	Santiago
Chile	#610	Santiago
Chile	#602	Talca
Chile	#600	Temuco
Chile	#601	Temuco
Chile	#611	Viña del Mar
New Zealand	#307	Auckland
New Zealand	#301	Christchurch	Canterbury
New Zealand	#304	Dunedin	Otago
New Zealand	#308	Hamilton
New Zealand	#306	Otara	Auckland
New Zealand	#305	Rotorua	Bay of Plenty
New Zealand	#302	Tauranga	Bay of Plenty
Paraguay	#704	Campos Cervera	Luque
Paraguay	#703	esquina Pai Perez	Asunción
Paraguay	#702	Florida	Asuncion
Paraguay	#707	Pai Perez	Asuncion
Peru	#505	Arequipa
Peru	#511	Callao
Peru	#506	Cusco
Peru	#513	ICA
Peru	#500	Lima
Peru	#501	Lima
Peru	#502	Lima
Peru	#504	Lima
Peru	#508	Lima
Peru	#509	Lima
Peru	#510	Lima
Peru	#512	Lima
Peru	#515	Lima
Peru	#516	Lima
Peru	#517	Lima
Peru	#514	Piura
Peru	#507	Trujillo
South Africa	#421	Benoni
South Africa	#402	Cape Town
South Africa	#405	Durban
South Africa	#406	Durban
South Africa	#408	Durban
South Africa	#412	Durban
South Africa	#414	Durban
South Africa	#404	Johannesburg
South Africa	#422	Kemptonpark
South Africa	#411	Kraaifontein
South Africa	#410	Krugersdorp
South Africa	#407	Port Elizabeth
South Africa	#409	Pretoria
South Africa	#413	Pretoria
South Africa	#415	Pretoria
South Africa	#418	Pretoria
South Africa	#419	Pretoria
South Africa	#420	Pretoria
South Africa	#423	Pretoria
South Africa	#417	Sandton
South Africa	#416	Somerset West
South Africa	#401	Soweto
United States	#142	Alexandria	Virginia
United States	#800	Alexandria	Virginia
United States	#823	Alexandria	Louisiana
United States	#001	Amarillo	Texas
United States	#059	Anaheim	California
United States	#179	Anaheim	California
United States	#812	Arlington	Texas
United States	#137	Austin	Texas
United States	#801	Baton Rouge	Louisiana
United States	#037	Beaumont	Texas
United States	#015	Bellevue	Nebraska
United States	#170	Bellevue	Nebraska
United States	#065	Birmingham	Alabama
United States	#022	Boca Raton	Florida
United States	#063	Boise	Idaho
United States	#152	Boynton Beach	Florida
United States	#197	Bridgeport	Connecticut
United States	#024	Bridgeville	Pennsylvania
United States	#171	Brooklyn	New York
United States	#113	Bryan	Texas
United States	#030	Carlisle	Ohio
United States	#058	Carrollton	Texas
United States	#089	Chandler	Arizona
United States	#032	Chino	California
United States	#815	Clairton	Pennsylvania
United States	#084	Clarksville	Tennessee
United States	#006	Cleveland	Ohio
United States	#819	Clinton	South Carolina
United States	#060	Coral Gables	Florida
United States	#066	Corpus Christi	Texas
United States	#168	Council Bluffs	Iowa
United States	#154	Cypress	California
United States	#007	Delray Beach	Florida
United States	#811	Detroit	Michigan
United States	#822	Draper	Utah
United States	#805	Easley	South Carolina
United States	#086	Edgewater	Florida
United States	#048	Elkridge	Maryland
United States	#011	Endwell	New York
United States	#804	Fishers	Indiana
United States	#803	Franklin	Indiana
United States	#016	Ft. Myers	Florida
United States	#038	Gainesville	Florida
United States	#004	Garden Grove	California
United States	#018	Green Valley	Arizona
United States	#198	Greenfield	Indiana
United States	#182	Grove City	Ohio
United States	#192	Harleysville	Pennsylvania
United States	#021	Harrisburg	North Carolina
United States	#055	Hazard	Kentucky
United States	#112	Henderson	Nevada
United States	#146	Henderson	Nevada
United States	#014	Hialeah	Florida
United States	#052	Hialeah	Florida
United States	#088	Hialeah	Florida
United States	#178	High Point	North Carolina
United States	#080	Honolulu	Hawaii
United States	#039	Houston	Texas
United States	#053	Houston	Texas
United States	#132	Houston	Texas
United States	#136	Houston	Texas
United States	#157	Houston	Texas
United States	#156	Huntsville	Alabama
United States	#035	Jacksonville	Florida
United States	#194	Johnston	Rhode Island
United States	#107	Jonesboro	Arkansas
United States	#158	Katy	Texas
United States	#094	Kissimmee	Florida
United States	#153	Kissimmee	Florida
United States	#079	Las Vegas	Nevada
United States	#176	Las Vegas	Nevada
United States	#177	Lauderdale Lakes	Florida
United States	#081	Lincoln	Nebraska
United States	#144	Long Beach	California
United States	#043	Los Angeles	California
United States	#139	Los Angeles	California
United States	#012	Melbourne	Florida
United States	#110	Mesa	Arizona
United States	#034	Miami	Florida
United States	#040	Miami	Florida
United States	#047	Miami	Florida
United States	#082	Miami	Florida
United States	#166	Miami	Florida
United States	#149	Miami Gardens	Florida
United States	#151	Mobile	Alabama
United States	#189	Morganton	North Carolina
United States	#195	Munci	Indiana
United States	#160	Murrells Inlet	South Carolina
United States	#164	New York	New York
United States	#008	Newton	Kansas
United States	#019	North Little Rock	Arkansas
United States	#835	Oak Lawn	Illinois
United States	#167	Oklahoma City	Oklahoma
United States	#810	Oklahoma City	Oklahoma
United States	#017	Omaha	Nebraska
United States	#041	Omaha	Nebraska
United States	#169	Omaha	Nebraska
United States	#833	Orangeburg	South Carolina
United States	#090	Orem	Utah
United States	#096	Oxnard	California
United States	#091	Pacific Palisades	California
United States	#114	Pasadena	California
United States	#831	Pawleys Island	South Carolina
United States	#816	Philladelphia	Pennsylvania
United States	#105	Phoenix	Arizona
United States	#111	Pico Rivera	California
United States	#134	Pinellas Park	Florida
United States	#191	Pittsburgh	Pennsylvania
United States	#097	Pomona	California
United States	#050	Port Orange	Florida
United States	#045	Portland	Oregon
United States	#002	Rapid City	South Dakota
United States	#009	Richmond	Virginia
United States	#068	Sacramento	California
United States	#117	Salt Lake City	Utah
United States	#832	Salt Lake City	Utah
United States	#003	San Antonio	Texas
United States	#108	San Antonio	Texas
United States	#180	San Antonio	Texas
United States	#817	San Antonio	Texas
United States	#818	San Antonio	Texas
United States	#035	San Diego	California
United States	#054	San Diego	California
United States	#828	Scottdale	Pennsylvania
United States	#155	Scottsboro	Alabama
United States	#140	Searcy	Arkansas
United States	#138	Shawnee	Kansas
United States	#085	Silver Spring	Maryland
United States	#147	Simpsonville	South Carolina
United States	#814	Snellville	Georgia
United States	#825	South Jordan	Utah
United States	#172	Spokane	Washington
United States	#830	Sugar Land	Texas
United States	#135	Tomball	Texas
United States	#809	Tomball	Texas
United States	#173	Toney	Alabama
United States	#042	Torrance	California
United States	#188	Tucson	Arizona
United States	#071	Tulsa	Oklahoma
United States	#161	Tuscumbia	Alabama
United States	#824	Uniontown	Pennsylvania
United States	#163	Venice	Florida
United States	#083	Wadsworth	Ohio
United States	#827	West Des Moines	Iowa
United States	#133	West Jordan	Utah
United States	#020	West Palm Beach	Florida
United States	#106	Wichita	Kansas
United States	#187	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MDVI, LLC

Countries where clinical trial is conducted

United States,  Australia,  Chile,  New Zealand,  Paraguay,  Peru,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	22 weeks	No