Clinical trial NCT03381196: A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza A
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-12-21
Enrollment: 553
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

Detailed description: This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (greater than \[\>\] 65 but less than or equal to \[\<=\] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.

Eligibility criteria: Inclusion Criteria:

* Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
* Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
* Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (\<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
* Enrollment and initiation of study drug treatment less than or equal to (\<=)72 hours after onset of influenza symptoms
* Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease \[COPD\] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus \[HIV\], cancer, or chronic liver or kidney disease \[presence of kidney damage for \>3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests\], or participants taking chronic systemic steroids)

Exclusion Criteria:

* Received more than (\>)1 dose of influenza antiviral medication (for example, oseltamivir \[OST\] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir \>1 day prior to screening
* Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
* Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
* Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
* Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus \[CD4+\] count \<200 cells per cubic millimeter \[cells/mm\^3\], absolute neutrophil count \<750/mm\^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)

Primary outcomes:
measure: Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Number of Participants Hospitalized After Treatment Initiation
timeFrame: Up to Day 28
measure: Viral Load Over Time
timeFrame: Baseline, Day 3, 6, 10, 14
measure: Number of Participants With Emergence of Viral Resistance to Pimodivir
timeFrame: Up to Day 28
measure: Plasma Concentration of Pimodivir
timeFrame: Day 3, 6, 7
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Changes in Laboratory Tests
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
timeFrame: Up to Day 28
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research Inc
state: Alabama
city: Scottsboro
country: United States
facility: Scottsboro Quick Care Clinic
state: Alabama
city: California City
country: United States
facility: SC Clinical Research Inc.
state: California
city: Fresno
country: United States
facility: Research Center of Fresno Inc
state: California
city: Gold River
country: United States
facility: Allied Clinical Research
state: California
city: Harbor City
country: United States
facility: Innovative Clinical Research Inc
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
city: Los Angeles
country: United States
facility: Downtown LA Research Center, Inc
state: California
city: Los Angeles
country: United States
facility: California Allergy & Asthma Medical Group Inc.
state: California
city: Los Angeles
country: United States
facility: Adam D. Karns, MD
state: California
city: Norwalk
country: United States
facility: Lucita M. Cruz Md Inc
state: California
city: Panorama City
country: United States
facility: Asclepes Research
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials LLC
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Sports Medicine & Family Health Center
state: California
city: San Ramon
country: United States
facility: West Coast Clinical Research, LLC
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute
state: Colorado
city: Northglenn
country: United States
facility: Complete Family Care
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: Colorado
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Doral
country: United States
facility: Moonshine Research Center, Inc
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research Inc
state: Florida
city: Hialeah
country: United States
facility: Floridian Clinical Research LLC
state: Florida
city: Hialeah
country: United States
facility: The community Research of South Florida
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: Homestead
country: United States
facility: Homestead Associates in Research Inc
state: Florida
city: Jacksonville
country: United States
facility: Care Partners Clinical Research
state: Florida
city: Lady Lake
country: United States
facility: Premier Medical Group
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Sima Research Clinic
state: Florida
city: Miami
country: United States
facility: Universal Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: South Florida Research Center Inc.
state: Florida
city: Miami
country: United States
facility: A Plus Research
state: Florida
city: Miami
country: United States
facility: Nuren Medical & Research Center
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando
state: Florida
city: Orlando
country: United States
facility: Clinical NeuroScience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center Inc
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research, LLC
state: Florida
city: Santa Rosa Beach
country: United States
facility: Destin Pulmonary Critical Care, PLLS.
state: Florida
city: Tamarac
country: United States
facility: Vita Health and Medical center
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research
state: Florida
city: Wellington
country: United States
facility: Axcess Medical Research, LLC
state: Florida
city: Zephyrhills
country: United States
facility: Cozy Research, Llc
state: Florida
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Lexington
country: United States
facility: The Research Group of Lexington, LLC
state: Kentucky
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Metairie
country: United States
facility: Medpharmics, LLC
state: Louisiana
city: Shreveport
country: United States
facility: North Star Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University Of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Univ School of Medicine
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Sterling Heights
country: United States
facility: Tri County Research, Inc.
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare PLC
state: Michigan
city: Bridgeton
country: United States
facility: Craig A. Spiegel, MD
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: La Vista
country: United States
facility: Barrett Clinic P.C.
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Next Phase Research Alliance
state: Nevada
city: Newark
country: United States
facility: Saint Michaels Medical Center
state: New Jersey
city: Cary
country: United States
facility: Accellacare Research of Cary
state: North Carolina
city: Clemmons
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Gastonia
country: United States
facility: clinical research of Gastonia
state: North Carolina
city: Hickory
country: United States
facility: Hickory Research Center.
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morganton
country: United States
facility: Burke Primary Care
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center LLC
state: North Carolina
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Hilliard
country: United States
facility: Buckeye Health and Research, LLC
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Lansdale
country: United States
facility: Detweiler Family Medicine and Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Research
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians Research
state: Pennsylvania
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Gaffney
country: United States
facility: Spectrum Medical Research
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Fusion Clinical Research of Spartanburg
state: South Carolina
city: West Columbia
country: United States
facility: Invocare Clinical Research Center
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Jefferson City
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Arlington
country: United States
facility: HIRG, LLC dba Health Innovation Research Group
state: Texas
city: Austin
country: United States
facility: ACRC Trials
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: DeSoto
country: United States
facility: WR-Global Medical Research, LLC
state: Texas
city: Galveston
country: United States
facility: University Of Texas Medical Branch At Galveston
state: Texas
city: Georgetown
country: United States
facility: San Gabriel Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: Houston
country: United States
facility: West Houston Clinical Research Service
state: Texas
city: Houston
country: United States
facility: Northwest Med Care,P.A.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Dairy Ashford Family Practice
state: Texas
city: Houston
country: United States
facility: JM Research.PLLC
state: Texas
city: Houston
country: United States
facility: PCP for Life
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research LLC
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: San Antonio
country: United States
facility: Tekton Research Inc.
state: Texas
city: San Antonio
country: United States
facility: DM Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Bountiful
country: United States
facility: Val Hansen
state: Utah
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Draper
country: United States
facility: J. Lewis research Inc./ Foothill Family Clinic South
state: Utah
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Riverton
country: United States
facility: Granger Medical Clinic-Riverton
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis research Inc./ Foothill Family Care
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis research Inc./ Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc/ FirstMed East
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research Inc./Jordan River Family Medicine
state: Utah
city: Arlington
country: United States
facility: Millennium Clinical Trials LLC
state: Virginia
city: Bahia Blanca
country: Argentina
facility: Hospital Interzonal General de Agudos Dr. Jose Penna
city: Ciudad de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Cordoba
country: Argentina
facility: Hospital Nuestra Señora de la Misericordia
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Cordoba
country: Argentina
facility: Hospital Cordoba
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Córdoba
country: Argentina
facility: Hospital Rawson
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: General Roca
country: Argentina
facility: Sanatorio Juan XXIII
city: Ituzaingo
country: Argentina
facility: Sanatorio del Oeste Ituzaingo
city: La Plata Lpl Lpl
country: Argentina
facility: Hospital Italiano de La Plata
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Rosario
country: Argentina
facility: Sanatorio Britanico S.A.
city: Santa Fe
country: Argentina
facility: Instituto Del Buen Aire
city: Coffs Harbour
country: Australia
facility: Northside Health
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Wien
country: Austria
facility: AKH - Medizinische Universitat Wien
city: Wien
country: Austria
facility: SMZ Süd - Kaiser Franz Josef Spital Wien
city: Brussel
country: Belgium
facility: Hopital Erasme
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Gozée
country: Belgium
facility: De Meulemeester, Marc
city: Ham
country: Belgium
facility: Jaak Mortelmans
city: Herbeumont
country: Belgium
facility: Quartier du Furgy 4
city: Linkebeek
country: Belgium
facility: Research Link
city: Massemen
country: Belgium
facility: BVBA Dr. Luc Capiau
city: Tessenderlo
country: Belgium
facility: Testumed
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Brasil
country: Brazil
facility: Infection Control Ltda
city: Canoas
country: Brazil
facility: Hrpc Ulbratech - Ulbra
city: Jau
country: Brazil
facility: Centro de Estudos Clínicos do Interior Paulista - CECIP
city: Juiz de Fora
country: Brazil
facility: CMIP - Centro Mineiro de Pesquisa Ltda
city: Passo Fundo
country: Brazil
facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
city: Santo André
country: Brazil
facility: Pesquisare Saude
city: Sao Paulo
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Jose Luiz Egydio Setubal
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: Ruse
country: Bulgaria
facility: SHATPPD - Ruse Ltd.
city: Sofia
country: Bulgaria
facility: MHAT Knyaginya Klementina
city: Sofia
country: Bulgaria
facility: MHAT 'Lyulin' EAD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Sofia
country: Bulgaria
facility: DCC II- Sofia EOOD
city: Sofia
country: Bulgaria
facility: Medical Center 'N. I. Pirogov', EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Sofia
city: Veliko Tarnovo
country: Bulgaria
facility: MHAT Dr Stefan Cherkezov
city: Vidin
country: Bulgaria
facility: MC 'Sv. Ivan Rilski', OOD
city: Red Deer
country: Canada
facility: The Bailey Clinic
state: Alberta
city: Mount Pearl
country: Canada
facility: Commonwealth Medical Clinic
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Aggarwal and associates Ltd
state: Ontario
city: NewMarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Quebec
country: Canada
facility: Recherche Clinique Sigma Inc.
city: San Bernardo
country: Chile
facility: Hospital El Pino
city: Talca
country: Chile
facility: Centro de Investigacion del Maule
city: Viña
country: Chile
facility: Hospital de Niños y Cunas
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Command
city: NanChang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
city: Ceske Budejovice
country: Czechia
facility: ADMED s.r.o.
city: Ceské Budejovice
country: Czechia
facility: Sanare, s.r.o.
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, p.o.
city: Pribram
country: Czechia
facility: Praktik Pb s.r.o
city: Slany
country: Czechia
facility: SARKAMED s.r.o.
city: Sokolov
country: Czechia
facility: Prakticky lekar
city: Paide
country: Estonia
facility: Private GP Ilme Last
city: Paide
country: Estonia
facility: Vee Family Doctor's Center OY
city: Tallinn
country: Estonia
facility: OU Innomedica
city: Tallinn
country: Estonia
facility: Merelahe Family Doctors Center
city: Tallinn
country: Estonia
facility: Pirita Family Doctors Centre
city: Tartu
country: Estonia
facility: Family Doctors Pullerits & Gavronski
city: Agen cedex 9
country: France
facility: Centre Hospitalier d'Agen
city: Creteil cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: La Roche S/ Yon Cedex 9
country: France
facility: Centre Hospitalier Départemental
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: Nantes Cedex 1
country: France
facility: CHU Nantes - Hotel Dieu
city: Nice Cedex 3
country: France
facility: CHU De Nice Hopital De l'Archet
city: Paris 75
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Cottbus
country: Germany
facility: MECS GmbH Cottbus
city: Deggingen
country: Germany
facility: Jung, Thomas
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Koeln
country: Germany
facility: Universitaetsklinikum Koelnt
city: Kuenzing
country: Germany
facility: Gemeinschaftspraxis Dr. Klein/ Minnich
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
city: Balatonfured
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
city: Budapest
country: Hungary
facility: Strázsahegy Medicina Bt
city: Budapest
country: Hungary
facility: Pestszentimrei Gyermekrendelő
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Miskolc
country: Hungary
facility: Futurenest Klinikai Kutato Kft.
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Nyiregyhaza
country: Hungary
facility: Borbanya Praxis Eu. Kft.
city: Nyiregyhaza
country: Hungary
facility: Medifarma-98 Kft.
city: Szentendre
country: Hungary
facility: DRC Szentendre
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Zamardi
country: Hungary
facility: DRC Zamardi
city: Zirc
country: Hungary
facility: DRC Zirc
city: Balaga
country: India
facility: Rajiv Gandhi Institute of Medical Sciences
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Jaipur
country: India
facility: S. R. Kalla Memorial General Hospital
city: Lucknow
country: India
facility: Midland Healthcare & Research Center
city: Manipal
country: India
facility: Kasturba Medical College Hospital
city: Nagpur
country: India
facility: Suretech Hospital and Research Centre Limited
city: Nashik
country: India
facility: Siddhi Hospital
city: New Delhi
country: India
facility: BLK Super Specialty Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Pune
country: India
facility: Lifepoint Multispecialty Hospital
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Surat
country: India
facility: Unique Hospital
city: Surat
country: India
facility: BAPS Pramukhswami Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon si
country: Korea, Republic of
facility: The Catholic university of Korea ST Vincent Hospital
city: Balvi
country: Latvia
facility: Liga Kozlovska family doctor practice
city: Daugavpils
country: Latvia
facility: OLVI Medical Centre
city: Jelgava
country: Latvia
facility: Baiba Bake GP practice
city: Kuldiga
country: Latvia
facility: Ruta Eglite's Private Practice
city: Liepaja
country: Latvia
facility: Inese Cebere GP practice
city: Ogre
country: Latvia
facility: S. Boreiko Doctor's Practice
city: Riga
country: Latvia
facility: Children's Clinical University Hospital
city: Riga
country: Latvia
facility: Clinic of GP A.Lasmanis 'ALMA'
city: Riga
country: Latvia
facility: Health Centre 4
city: Tukums
country: Latvia
facility: Inese Petrova General Practitioner Practice
city: Ventspils
country: Latvia
facility: Medical Practice BINI
city: Kaunas
country: Lithuania
facility: Auki Sveikas
city: Kaunas
country: Lithuania
facility: Silainiai Family Health Center, JSC
city: Kaunas
country: Lithuania
facility: Saules Seimos Medicinos Centras, JSC
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Inlita, JSC, Lazdynai KTC clinical trial site
city: Vilnius
country: Lithuania
facility: Central Outpatient Clinic
city: Vilnius
country: Lithuania
facility: Inlita, JSC
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos, Public Institution
city: Cheras Baru
country: Malaysia
facility: Klinik Kesihatan Cheras Baru
city: Kuang
country: Malaysia
facility: Klinik Kesihatan Kuang
city: Miri
country: Malaysia
facility: Hospital Miri
city: Taiping
country: Malaysia
facility: Hospital Taiping
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Ciudad De Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
city: Culiacan
country: Mexico
facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca
city: Jojutla De Juárez
country: Mexico
facility: Centro Medico Jojutla
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
city: Pahucha
country: Mexico
facility: Clinical Trials Mexico S.A. de C.V.
city: Den Haag
country: Netherlands
facility: Huisartsenpraktijk Mangal
city: Rotterdam
country: Netherlands
facility: Huisartsenpraktijk Zijtregtop
city: Zwijndrecht
country: Netherlands
facility: Huisartsenpraktijk Top
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Papamoa
country: New Zealand
facility: Culloden Research Ltd
city: Rotorua
country: New Zealand
facility: Lakeland Family Medical Services Ltd
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Lima
country: Peru
facility: Complejo Hospitalario San Pablo
city: Lima
country: Peru
facility: Clínica Sanna San Borja
city: Lima
country: Peru
facility: Clínica Internacional
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora
city: Trujillo
country: Peru
facility: Clinica Peruano Americana S.A
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
city: Lancut
country: Poland
facility: Centrum Medyczne w Lancucie Sp.z o.o.
city: Lodz
country: Poland
facility: ETG Lodz
city: Specjalistyczna W Brzegu Dolnym
country: Poland
facility: Powiatowe Centrum Medyczne w Wolowie Sp z o o
city: Sucha Beskidzka
country: Poland
facility: Gabinet Lekarski Pediatryczno-Alergologiczny
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
city: Kazan
country: Russian Federation
facility: Institute Of Epidimiology And Microbiology
city: Omsk
country: Russian Federation
facility: Limited Liability company 'MSMC' Euromed
city: Saint-Petersburg
country: Russian Federation
facility: LLC Outpatient department of Private Security Guards and Detectives
city: Saint-Petersburg
country: Russian Federation
facility: LLC Institute of Medical Examinations
city: Saint-Petersburg
country: Russian Federation
facility: FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF
city: St. Petersburg
country: Russian Federation
facility: LLC Kurator
city: Stavropol
country: Russian Federation
facility: LLC 'ArsVite'
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: Yaroslavl
country: Russian Federation
facility: SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF
city: Kosice
country: Slovakia
facility: Alersa, S.R.O.
city: Michalovce
country: Slovakia
facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
city: Spisska Nova Ves
country: Slovakia
facility: Plucna ambulancia Hrebenar, s.r.o.
city: Svidnik
country: Slovakia
facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
city: Alberton
country: South Africa
facility: Cardiology Clinical Research
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Brandfort
country: South Africa
facility: Moriana Clinical Research
city: Breyten
country: South Africa
facility: Dr Dindar & Partner
city: Cape Town
country: South Africa
facility: Endocare Research
city: Cape Town
country: South Africa
facility: Uhuru Clinical Trial Centre
city: Cape Town
country: South Africa
facility: Dr EL Janari Private Practice
city: Chatsworth
country: South Africa
facility: Precise Clinical Solutions
city: Durban North
country: South Africa
facility: Global Clinical Research SA
city: Durban
country: South Africa
facility: Abdullah, IA
city: Durban
country: South Africa
facility: Sebastian, Peter
city: Durban
country: South Africa
facility: Pillai, P
city: Durban
country: South Africa
facility: Govind, U
city: Durban
country: South Africa
facility: Jeevren Reddy, MD
city: Johannesburg
country: South Africa
facility: CRISMO Bertha Gxowa Research Centre
city: Kempton Park
country: South Africa
facility: Peermed Clinical Trial Centre
city: Krugersdorp
country: South Africa
facility: DJW Research
city: KwaZulu-Natal
country: South Africa
facility: Aliwal Shoal Medical Centre
city: Midrand
country: South Africa
facility: Dr A Jacovides Clinical Trials Inc.
city: Moloto
country: South Africa
facility: Dr AA Mahomed Medical Centre
city: Newtown
country: South Africa
facility: Newtown Clinical Research
city: Ottawa
country: South Africa
facility: Pillay, SR
city: Port Elizabeth
country: South Africa
facility: Smartmed Research Centre
city: Pretoria
country: South Africa
facility: Emmed Research
city: Pretoria
country: South Africa
facility: Botho ke Bontle Health Services
city: Pretoria
country: South Africa
facility: Into Research
city: Pretoria
country: South Africa
facility: Jongaie Research
city: Pretoria
country: South Africa
facility: Queenswood Clinical Trial Centre
city: Pretoria
country: South Africa
facility: Engelbrecht, I
city: Pretoria
country: South Africa
facility: Johese Clinical Research
city: Soweto
country: South Africa
facility: Wits Clinical Research
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
city: Van Der Bijl
country: South Africa
facility: Clinteam Vaal Clinical Trial Centre
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
city: Elche
country: Spain
facility: Hosp. Gral. Univ. de Elche
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. Hm Monteprincipe
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Malmö
country: Sweden
facility: Department for Heart Failure and Valvular Disease
city: Stockholm
country: Sweden
facility: City Diabetes
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital, Shalu
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
city: Bangkok
country: Thailand
facility: The Hospital for Tropical Diseases
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Muang
country: Thailand
facility: Srinagarind Hospital
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
city: Wattana
country: Thailand
facility: Bumrungrad Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Aydin
country: Turkey
facility: Adnan Menderes University
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty
city: Diyarbakir
country: Turkey
facility: Diyarbakir University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Samanpazari
country: Turkey
facility: Hacettepe University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: Kharkiv
country: Ukraine
facility: Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE
city: Kyiv
country: Ukraine
facility: Kyiv Oleksandrivska Clinical Hospital
city: Odesa
country: Ukraine
facility: Odesa City Municipal Institution Polyclinic #20
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
city: Bolton
country: United Kingdom
facility: Swan Lane Medical Centre
city: Manchester
country: United Kingdom
facility: Bodey Medical Centre
city: Manchester
country: United Kingdom
facility: Barlow Medical Centre
city: Manchester
country: United Kingdom
facility: West Timperley Medical Centre
city: Northenden
country: United Kingdom
facility: Northenden Group Practice
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Diseases
city: Ho Chi Minh
country: Vietnam
facility: Nguyen Tri Phuong Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: