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

April 30, 2021 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

553

Phase

  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina, B8001DDU
        • Hospital Interzonal General de Agudos Dr. Jose Penna
      • Ciudad de Buenos Aires, Argentina, 1431
        • CEMIC Saavedra
      • Cordoba, Argentina, X5000JHQ
        • Sanatorio Allende
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba
      • Cordoba, Argentina, 5000
        • Hospital Nuestra Senora de la Misericordia
      • Cordoba, Argentina, X5004CDT
        • Hospital Córdoba
      • Córdoba, Argentina, 5000
        • Hospital San Roque
      • Córdoba, Argentina, 5000
        • Hospital Rawson
      • General Roca, Argentina, 8332
        • Sanatorio Juan XXIII
      • Ituzaingo, Argentina, 1714
        • Sanatorio del Oeste Ituzaingo
      • La Plata, Argentina, B1900AVG
        • Instituto Medico Platense
      • La Plata Lpl Lpl, Argentina, 1900
        • Hospital Italiano de La Plata
      • Rosario, Argentina, 2000
        • Sanatorio Britanico S.A.
      • Santa Fe, Argentina, 3000
        • Instituto Del Buen Aire
  • Australia
      • Coffs Harbour, Australia, 2450
        • Northside Health
      • South Brisbane, Australia, 4101
        • Mater Hospital Brisbane
  • Austria
      • Wien, Austria, 1090
        • AKH - Medizinische Universitat Wien
      • Wien, Austria, 1100
        • SMZ Süd - Kaiser Franz Josef Spital Wien
  • Belgium
      • Brussel, Belgium, 1070
        • Hôpital Erasme
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1000
        • CHU Saint-Pierre
      • Gozée, Belgium, 6534
        • De Meulemeester, Marc
      • Ham, Belgium, 3945
        • Jaak Mortelmans
      • Herbeumont, Belgium, 6887
        • Quartier du Furgy 4
      • Linkebeek, Belgium, 1630
        • Research Link
      • Massemen, Belgium, 9230
        • BVBA Dr. Luc Capiau
      • Tessenderlo, Belgium, 3980
        • Testumed
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Santa Casa de Misericórdia de Belo Horizonte
      • Brasil, Brazil, 30110-063
        • Infection Control Ltda
      • Canoas, Brazil, 92425
        • Hrpc Ulbratech - Ulbra
      • Jaú, Brazil, 17201-150
        • Centro de Estudos Clínicos do Interior Paulista - CECIP
      • Juiz de Fora, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa
      • Passo Fundo, Brazil, 99010-080
        • Hospital Sao Vicente de Paulo
      • Porto Alegre, Brazil, 90610-000
        • Hospital São Lucas da PUCRS
      • Porto Alegre, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Rio de Janeiro, Brazil, 22271-100
        • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
      • Santo André, Brazil, 09080-110
        • Pesquisare Saude
      • São Bernardo do Campo, Brazil, 09780-000
        • CEMEC - Centro Multidisciplinar de Estudos Clínicos
      • São Paulo, Brazil, 01221-020
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
      • São Paulo, Brazil, 01227-200
        • Fundacao Jose Luiz Egydio Setubal
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • SHATPPD - Ruse Ltd.
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital
      • Sofia, Bulgaria, 1233
        • Fifth MHAT - Sofia
      • Sofia, Bulgaria, 1336
        • MHAT 'Lyulin' EAD
      • Sofia, Bulgaria, 1606
        • DCC II- Sofia EOOD
      • Sofia, Bulgaria, 1606
        • Medical Center 'N. I. Pirogov', EOOD
      • Sofia, Bulgaria, 1606
        • Medical Center Excelsior OOD
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - Sofia
      • Veliko Tarnovo, Bulgaria, 5000
        • MHAT Dr Stefan Cherkezov
      • Vidin, Bulgaria, 3700
        • MC 'Sv. Ivan Rilski', OOD
  • Canada
      • Mount Pearl, Canada, A1N 1W7
        • Commonwealth Medical Clinic
      • Quebec, Canada, G1G 4A2
        • Recherche Clinique Sigma Inc.
    • Alberta
      • Red Deer, Alberta, Canada, T4N 6V7
        • The Bailey Clinic
    • Ontario
      • Brampton, Ontario, Canada
        • Aggarwal and associates Ltd
      • NewMarket, Ontario, Canada, L3Y 5G8
        • SKDS Research Inc.
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K Gupta Medicine Professional Corporation
  • Chile
      • San Bernardo, Chile
        • Hospital El Pino
      • Talca, Chile, 00000
        • Centro de Investigacion del Maule
      • Viña, Chile
        • Hospital de Niños y Cunas
  • China
      • Beijing, China, 100853
        • Chinese PLA General Hospital
      • Fuzhou, China, 350000
        • Fuzhou General hospital of Nanjing Military Command
      • NanChang, China, 330006
        • The first affiliated Hospital of Nanchang University
      • Wuxi, China, 214000
        • Wuxi People's Hospital
      • Zhengzhou, China
        • Henan province people's hospital
  • Czechia
      • Ceske Budejovice, Czechia, 37006
        • ADMED s.r.o.
      • Ceské Budejovice, Czechia, 37006
        • Sanare, s.r.o.
      • Kyjov, Czechia, 697 01
        • Nemocnice Kyjov, p.o.
      • Pribram, Czechia, 26101
        • Praktik Pb s.r.o
      • Slany, Czechia, 274 01
        • Sarkamed s.r.o.
      • Sokolov, Czechia, 356 01
        • Prakticky lekar
  • Estonia
      • Paide, Estonia, 72713
        • Vee Family Doctor's Center OY
      • Paide, Estonia, 72712
        • Private GP Ilme Last
      • Tallinn, Estonia, 11911
        • Pirita Family Doctors Centre
      • Tallinn, Estonia, 10117
        • OU Innomedica
      • Tallinn, Estonia, 10617
        • Merelahe Family Doctors Center
      • Tartu, Estonia, 51014
        • Family Doctors Pullerits & Gavronski
  • France
      • Agen cedex 9, France, 47923
        • Centre Hospitalier d'Agen
      • Creteil cedex, France, 94010
        • Centre hospitalier intercommunal de Créteil
      • La Roche S/ Yon Cedex 9, France, 85925
        • Centre Hospitalier departemental
      • La Tronche, France, 38043
        • CHU de Grenoble - Hôpital Albert Michallon
      • Nantes Cedex 1, France, 44093
        • CHU Nantes - Hôtel Dieu
      • Nice Cedex 3, France, 06202
        • CHU de Nice, Hopital de l'Archet
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris 75, France, 75679 Cedex 14
        • Hôpital COCHIN
  • Germany
      • Cottbus, Germany, 03050
        • MECS GmbH Cottbus
      • Deggingen, Germany, 73326
        • Jung, Thomas
      • Erlangen, Germany, 91054
        • Universitaetsklinik Erlangen
      • Giessen, Germany, 35392
        • Universitaetsklinikum Giessen und Marburg GmbH
      • Koeln, Germany, 50937
        • Universitaetsklinikum Koeln
      • Kuenzing, Germany, 94550
        • Gemeinschaftspraxis Dr. Klein/ Minnich
      • Leipzig, Germany, 04249
        • Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft.
      • Budapest, Hungary, 1122
        • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
      • Budapest, Hungary, 1171
        • Egeszsegkert Medicina Bt.
      • Budapest, Hungary, 1188
        • Pestszentimrei Gyermekrendelő
      • Gyongyos, Hungary, 3200
        • Bugát Pál Kórház
      • Miskolc, Hungary, 3527
        • Futurenest Klinikai Kutató Kft.
      • Mohacs, Hungary, 7700
        • Mohacsi Korhaz
      • Nyiregyhaza, Hungary, 4400
        • Medifarma-98 Kft.
      • Nyiregyhaza, Hungary, 4400
        • Borbanya Praxis Eu. Kft.
      • Szentendre, Hungary, 2000
        • DRC Szentendre
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
      • Zamardi, Hungary, 8621
        • DRC Zamardi
      • Zirc, Hungary, 8420
        • DRC Zirc
  • India
      • Balaga, India, 532001
        • Rajiv Gandhi Institute of Medical Sciences
      • Bangalore, India, 560054
        • M S Ramaiah Memorial Hospital
      • Jaipur, India, 302001
        • S. R. Kalla Memorial General Hospital
      • Lucknow, India, 226006
        • Midland Healthcare & Research Center
      • Manipal, India, 576104
        • Kasturba Medical College Hospital
      • Nagpur, India, 400012
        • Suretech Hospital and Research Centre Limited
      • Nashik, India, 422007
        • Siddhi Hospital
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110005
        • BLK Super Specialty Hospital
      • Pune, India, 411004
        • Sahyadri Speciality Hospital
      • Pune, India, 411023
        • Lifepoint Multispecialty Hospital
      • Rajkot, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, India, 395009
        • BAPS Pramukhswami Hospital
      • Surat, India, 395002
        • Unique Hospital
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Nahariya, Israel, 22100
        • Galilee Medical Center
      • Ramat Gan, Israel, 52621
        • Chaim Sheba Medical Center
      • Rechovot, Israel, 7610001
        • Kaplan Medical Center
      • Safed, Israel, 13100
        • Ziv Medical Center
  • Italy
      • Milano, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda
      • Modena, Italy, 41124
        • AOU Policlinico di Modena
      • Monza, Italy, 20052
        • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
      • Verona, Italy, 37126
        • Azienda Ospedaliera Universitaria integrata Verona
  • Korea, Republic of
      • Ansan-si, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Gangwon-do, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
      • Hwaseong-si, Korea, Republic of, 18450
        • Hallym University Dongtan Sacred Heart Hospital
      • Incheon, Korea, Republic of, 22322
        • Inha University Hospital
      • Incheon, Korea, Republic of, 403-720
        • The Catholic University of Korea, Incheon St. Mary's Hospital
      • Pusan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea, Republic of, 8308
        • Korea University Guro Hospital
      • Suwon-si, Korea, Republic of, 16247
        • The Catholic university of Korea, ST Vincent Hospital
  • Latvia
      • Balvi, Latvia, LV4501
        • Liga Kozlovska family doctor practice
      • Daugavpils, Latvia, LV-5401
        • OLVI Medical Centre
      • Jelgava, Latvia, LV3001
        • Baiba Bake GP practice
      • Kuldiga, Latvia, LV-3301
        • Ruta Eglite's Private Practice
      • Liepaja, Latvia, LV-3401
        • Inese Cebere GP practice
      • Ogre, Latvia, LV-5001
        • S. Boreiko Doctor's Practice
      • Riga, Latvia, LV-1012
        • Health Centre 4
      • Riga, Latvia, LV-1004
        • Children's Clinical University Hospital
      • Riga, Latvia, LV-1010
        • Clinic of GP A.Lasmanis 'ALMA'
      • Tukums, Latvia, LV-3101
        • Inese Petrova General Practitioner Practice
      • Ventspils, Latvia, LV3601
        • Medical Practice BINI
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Kaunas, Lithuania, 44175
        • Auki Sveikas
      • Kaunas, Lithuania, 48259
        • Silainiai Family Health Center, JSC
      • Kaunas, Lithuania, 49449
        • Saules Seimos Medicinos Centras, JSC
      • Siauliai, Lithuania, 76231
        • Siauliai Republican Hospital, Public Institution
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santaros Klinikos, Public Institution
      • Vilnius, Lithuania, 4130
        • Inlita, JSC, Lazdynai KTC clinical trial site
      • Vilnius, Lithuania, LT-01117
        • Central Outpatient Clinic
      • Vilnius, Lithuania, LT-08406
        • Inlita, JSC
  • Malaysia
      • Cheras Baru, Malaysia, 56100
        • Klinik Kesihatan Cheras Baru
      • Kuang, Malaysia, 48050
        • Klinik Kesihatan Kuang
      • Miri, Malaysia, 98000
        • Hospital Miri
      • Taiping, Malaysia, 34000
        • Hospital Taiping
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Hospital Cardiologica Aguascalientes
      • Ciudad De Mexico, Mexico, 6720
        • Hospital Infantil de Mexico Federico Gomez
      • Culiacan, Mexico, 80230
        • Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.
      • Guadalajara, Mexico, 44280
        • Hospital Civil De Guadalajara Fray Antonio Alcalde
      • Guadalajara, Mexico, 44130
        • Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
      • Guadalajara, Mexico, 44340
        • Hospital Civil de Guadalajara Dr. Juan I. Menchaca
      • Jojutla De Juárez, Mexico, 62900
        • Centro Medico Jojutla
      • Monterrey, Mexico, 64460
        • Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
      • Pahucha, Mexico, 42070
        • Clinical Trials Mexico S.A. de C.V.
  • Netherlands
      • Den Haag, Netherlands, 2565 KV
        • Huisartsenpraktijk Mangal
      • Rotterdam, Netherlands, 3037 AN
        • Huisartsenpraktijk Zijtregtop
      • Zwijndrecht, Netherlands, 3334 SB
        • Huisartsenpraktijk Top
  • New Zealand
      • Auckland, New Zealand, 1050
        • Southern Clinical Trials Ltd
      • Papamoa, New Zealand, 3118
        • Culloden Research Ltd
      • Rotorua, New Zealand, 3010
        • Lakeland Family Medical Services Ltd
      • Wellington, New Zealand, 6021
        • Wellington Hospital
  • Peru
      • Lima, Peru, Lima 29
        • Hospital Maria Auxiliadora
      • Lima, Peru, 33
        • Complejo Hospitalario San Pablo
      • Lima, Peru, 41
        • Clínica Sanna San Borja
      • Lima, Peru, Lima 01
        • Clinica Internacional
      • Trujillo, Peru, 13007
        • Clinica Peruano Americana S.A
  • Poland
      • Krakow, Poland, 31-624
        • Malopolskie Centrum Alergologii
      • Lancut, Poland, 37-100
        • Centrum Medyczne w Lancucie Sp.z o.o.
      • Lodz, Poland, 90-302
        • ETG Lodz
      • Specjalistyczna W Brzegu Dolnym, Poland, 58-120
        • Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.
      • Sucha Beskidzka, Poland, 34-200
        • Gabinet Lekarski Pediatryczno-Alergologiczny
      • Wroclaw, Poland, 51-162
        • NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska
  • Russian Federation
      • Kazan, Russian Federation, 420015
        • Institute Of Epidimiology And Microbiology
      • Omsk, Russian Federation, 644024
        • Limited Liability company 'MSMC' Euromed
      • Saint-Petersburg, Russian Federation, 192007
        • LLC Outpatient department of Private Security Guards and Detectives
      • Saint-Petersburg, Russian Federation, 196084
        • LLC Institute of Medical Examinations
      • Saint-Petersburg, Russian Federation, 197376
        • FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF
      • St. Petersburg, Russian Federation, 196240
        • LLC Kurator
      • Stavropol, Russian Federation, 355020
        • LLC 'ArsVite'
      • Tomsk, Russian Federation, 634061
        • Siberian State Medical University
      • Yaroslavl, Russian Federation, 150007
        • Clinical Hospital #3
      • Yaroslavl, Russian Federation, 150010
        • SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF
  • Slovakia
      • Kosice, Slovakia, 04022
        • Alersa, S.R.O.
      • Michalovce, Slovakia, 07101
        • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
      • Spisska Nova Ves, Slovakia, 05201
        • Plucna ambulancia Hrebenar, s.r.o.
      • Svidnik, Slovakia, 08901
        • Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
  • South Africa
      • Alberton, South Africa, 1449
        • Cardiology Clinical Research
      • Bloemfontein, South Africa, 9301
        • Josha Research
      • Brandfort, South Africa, 9400
        • Moriana Clinical Research
      • Breyten, South Africa, 2330
        • Dr Dindar & Partner
      • Cape Town, South Africa, 7646
        • Endocare Research
      • Cape Town, South Africa, 7764
        • Uhuru Clinical Trial Centre
      • Cape Town, South Africa, 7945
        • Dr EL Janari Private Practice
      • Chatsworth, South Africa, 4092
        • Precise Clinical Solutions
      • Durban, South Africa, 4001
        • Abdullah, IA
      • Durban, South Africa, 4001
        • Sebastian, Peter
      • Durban, South Africa, 4068
        • Pillai, P
      • Durban, South Africa, 4096
        • Govind, U
      • Durban, South Africa, 4450
        • Jeevren Reddy, MD
      • Durban North, South Africa, 4051
        • Global Clinical Research SA
      • Johannesburg, South Africa, 1401
        • CRISMO Bertha Gxowa Research Centre
      • Kempton Park, South Africa, 1619
        • Peermed Clinical Trial Centre
      • Krugersdorp, South Africa, 1739
        • DJW Research
      • KwaZulu-Natal, South Africa, 4170
        • Aliwal Shoal Medical Centre
      • Midrand, South Africa, 1685
        • Dr A Jacovides Clinical Trials Inc.
      • Moloto, South Africa, 1022
        • Dr AA Mahomed Medical Centre
      • Newtown, South Africa, 2113
        • Newtown Clinical Research
      • Ottawa, South Africa, 4339
        • Pillay, SR
      • Port Elizabeth, South Africa, 6020
        • Smartmed Research Centre
      • Pretoria, South Africa, 0084
        • Emmed Research
      • Pretoria, South Africa, 0183
        • Jongaie Research
      • Pretoria, South Africa, 0101
        • Botho Ke Bontle Health Services
      • Pretoria, South Africa, 0181
        • Into Research
      • Pretoria, South Africa, 0186
        • Queenswood Clinical Trial Centre
      • Pretoria, South Africa, 157
        • Engelbrecht, I
      • Pretoria, South Africa, 1692
        • Johese Clinical Research
      • Soweto, South Africa, 2013
        • Wits Clinical Research
      • Thabazimbi, South Africa, 380
        • Limpopo Clinical Research Initiative
      • Van Der Bijl, South Africa, 1911
        • Clinteam Vaal Clinical Trial Centre
      • Welkom, South Africa, 9460
        • Welkom Clinical Trial Centre
  • Spain
      • Elche, Spain, 03203
        • Hosp. Gral. Univ. de Elche
      • Granada, Spain, 18014
        • Hosp. Univ. Virgen de Las Nieves
      • Granada, Spain, 18012
        • Hosp. Univ. San Cecilio
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28046
        • Hosp. Univ. La Paz
      • Madrid, Spain, 28006
        • Hosp. Univ. de La Princesa
      • Madrid, Spain, 28660
        • Hosp. Univ. Hm Monteprincipe
      • Santiago de Compostela, Spain, 15706
        • Hosp. Clinico Univ. de Santiago
      • Vigo, Spain, 36312
        • Hosp. Alvaro Cunqueiro
  • Sweden
      • Malmö, Sweden, 205 02
        • Department for Heart Failure and Valvular Disease
      • Stockholm, Sweden, 11157
        • City Diabetes
      • Umeå, Sweden, 901 87
        • Norrlands universitetssjukhus
      • Uppsala, Sweden, 75185
        • Akademiska Sjukhuset
  • Taiwan
      • New Taipei City, Taiwan, 23561
        • Taipei Medical University Shuang-Ho Hospital
      • Taichung, Taiwan
        • Kuang Tien General Hospital, Shalu
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 116
        • Taipei Medical University-Wan Fang Hospital
      • Taipei City, Taiwan, 110
        • Taipei Medical University
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • The Hospital for Tropical Diseases
      • Muang, Thailand, 40002
        • Srinagarind Hospital
      • Nonthaburi, Thailand, 11000
        • Bamrasnaradura Infectious Disease Institute
      • Wattana, Thailand, 10110
        • Bumrungrad Hospital
  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Aydin, Turkey, 09100
        • Adnan Menderes University
      • Bursa, Turkey, 16059
        • Uludag University Medical Faculty
      • Diyarbakir, Turkey, 21080
        • Diyarbakir University Medical Faculty
      • Kocaeli, Turkey, 41380
        • Kocaeli University Medical Faculty
      • Samanpazari, Altindag, Turkey, 06100
        • Hacettepe University Medical Faculty
      • Trabzon, Turkey, 61080
        • Karadeniz Teknik University Medical Faculty
  • Ukraine
      • Kharkiv, Ukraine, 61106
        • Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE
      • Kyiv, Ukraine, 1601
        • Kyiv Oleksandrivska Clinical Hospital
      • Odesa, Ukraine, 65114
        • Odesa City Municipal Institution Polyclinic #20
      • Poltava, Ukraine, 36000
        • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
      • Vinnytsia, Ukraine, 21021
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • United Kingdom
      • Bolton, United Kingdom, BL 6 6QT
        • Swan Lane Medical Centre
      • Manchester, United Kingdom, M20 2RN
        • Barlow Medical Centre
      • Manchester, United Kingdom, M14 6WP
        • Bodey Medical Centre
      • Manchester, United Kingdom, WA14 5PF
        • West Timperley Medical Centre
      • Northenden, United Kingdom, M22 4DH
        • Northenden Group Practice
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics, LLC
      • Birmingham, Alabama, United States, 35242
        • Cahaba Research Inc
      • Scottsboro, Alabama, United States, 35768
        • Scottsboro Quick Care Clinic
    • California
      • California City, California, United States, 92844
        • SC Clinical Research Inc.
      • Fresno, California, United States, 93702
        • Research Center of Fresno Inc
      • Gold River, California, United States, 95670
        • Allied Clinical Research
      • Harbor City, California, United States, 90710
        • Innovative Clinical Research, Inc.
      • Lancaster, California, United States, 93534
        • Om Research LLC
      • Long Beach, California, United States, 90806
        • Miller Children's Hospital
      • Long Beach, California, United States, 90806
        • Ark Clinical Research
      • Los Angeles, California, United States, 90025
        • California Allergy & Asthma Medical Group Inc.
      • Los Angeles, California, United States, 90017
        • Downtown LA Research Center, Inc
      • Los Angeles, California, United States, 90036
        • Adam D. Karns, MD
      • Norwalk, California, United States, 90650
        • Lucita M. Cruz Md Inc
      • Panorama City, California, United States, 91402
        • Asclepes Research
      • Paramount, California, United States, 90723
        • Center For Clinical Trials LLC
      • Sacramento, California, United States, 95684
        • Benchmark Research
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92129
        • San Diego Sports Medicine & Family Health Center
      • San Ramon, California, United States, 94582
        • West Coast Clinical Research, LLC
      • Stanford, California, United States, 94305-5640
        • Stanford University
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • Lynn Institute
      • Northglenn, Colorado, United States, 80234
        • Complete Family Care
      • Wheat Ridge, Colorado, United States, 80033
        • Paradigm Clinical Research Centers, Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20011
        • Emerson Clinical Research Institute
    • Florida
      • Doral, Florida, United States, 33166
        • Moonshine Research Center, Inc
      • Hialeah, Florida, United States, 33016
        • The Community Research of South Florida
      • Hialeah, Florida, United States, 33016
        • Best Quality Research Inc
      • Hialeah, Florida, United States, 33016
        • Floridian Clinical Research, LLC
      • Hollywood, Florida, United States, 46112
        • Encore Medical Research, LLC
      • Homestead, Florida, United States, 33032
        • Homestead Associates in Research, Inc
      • Jacksonville, Florida, United States, 32218
        • Care Partners Clinical Research
      • Lady Lake, Florida, United States, 32159
        • Premier Medical Group
      • Miami, Florida, United States, 33175
        • New Horizon Research Center
      • Miami, Florida, United States, 33176
        • Vista Health Research, LLC
      • Miami, Florida, United States, 33144
        • Nuren Medical & Research Center
      • Miami, Florida, United States, 33175
        • Coral Research Clinic Corp
      • Miami, Florida, United States, 33135
        • South Florida Research Center Inc.
      • Miami, Florida, United States, 33125
        • Sima Research Clinic
      • Miami, Florida, United States, 33134
        • Universal Clinical Research Associates
      • Miami, Florida, United States, 33144
        • A Plus Research
      • Miami Lakes, Florida, United States, 33014
        • Crystal Biomedical Research
      • Orlando, Florida, United States, 32810
        • Omega Research Consultants
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc
      • Orlando, Florida, United States, 32803
        • Combined Research Orlando
      • Pembroke Pines, Florida, United States, 33027
        • South Broward Research, LLC
      • Pembroke Pines, Florida, United States, 33026
        • Pines Care Research Center Inc
      • Santa Rosa Beach, Florida, United States, 32459
        • Destin Pulmonary Critical Care, PLLS.
      • Tamarac, Florida, United States, 33319
        • Vita Health and Medical center
      • Weeki Wachee, Florida, United States, 34607
        • Asclepes Research
      • Wellington, Florida, United States, 33414
        • Axcess Medical Research, LLC
      • Zephyrhills, Florida, United States, 33541
        • Cozy Research, LLC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
      • Nampa, Idaho, United States, 83686
        • Saltzer Medical Group
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Investigators Research Group, LLC
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
      • Shreveport, Louisiana, United States, 71104
        • North Star Clinical Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University School of Medicine
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ School of Medicine
      • Detroit, Michigan, United States, 97205
        • Wayne State University
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Sterling Heights, Michigan, United States, 48310-3503
        • Tri County Research, Inc.
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare, PLC
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Craig A. Spiegel, MD
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Barrett Clinic P.C.
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Next Phase Research Alliance
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • PMG Research
      • Clemmons, North Carolina, United States, 27012
        • Onsite Clinical Solutions
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Institute for Clinical Research
      • Gastonia, North Carolina, United States, 28054
        • Clinical Research of Gastonia
      • Hickory, North Carolina, United States, 28601
        • Hickory Research Center.
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Morganton, North Carolina, United States, 28655
        • Burke Primary Care
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Trials Of America
    • Ohio
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
      • Hilliard, Ohio, United States, 43027
        • Buckeye Health and Research, LLC
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 29720
        • Lancaster General Hospital
      • Lansdale, Pennsylvania, United States, 19446
        • Detweiler Family Medicine and Associates
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Healthcare Network
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians Research
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • AAPRI Clinical Research Institute
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Spectrum Medical Research
      • Greer, South Carolina, United States, 29651
        • DeGarmo Institute of Medical Research
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston, LLC
      • Spartanburg, South Carolina, United States, 29301
        • Fusion Clinical Research of Spartanburg
      • West Columbia, South Carolina, United States, 29169
        • Invocare Clinical Research Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol
      • Jefferson City, Tennessee, United States, 37760
        • PMG Research of Knoxville
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
    • Texas
      • Arlington, Texas, United States, 76014
        • HIRG, LLC dba Health Innovation Research Group
      • Austin, Texas, United States, 78735
        • ACRC Trials
      • Carrollton, Texas, United States, 75010
        • Family Medicine Associates of Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • DeSoto, Texas, United States, 75115
        • WR-Global Medical Research, LLC
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • Georgetown, Texas, United States, 78626
        • San Gabriel Clinical Research, LLC
      • Houston, Texas, United States, 77074
        • Southwest Clinical Trials
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Service
      • Houston, Texas, United States, 77043
        • BI Research Center
      • Houston, Texas, United States, 77070
        • Northwest Med Care,P.A.
      • Houston, Texas, United States, 77077
        • Dairy Ashford Family Practice
      • Houston, Texas, United States, 77083
        • JM Research.PLLC
      • Houston, Texas, United States, 77093-6731
        • PCP for Life
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research LLC
      • Plano, Texas, United States, 75024
        • Village Health Partners
      • San Antonio, Texas, United States, 78240
        • Tekton Research Inc.
      • San Antonio, Texas, United States, 78249
        • DM Clinical Research
      • The Woodlands, Texas, United States, 77380
        • Renovatio Clinical
      • Waxahachie, Texas, United States, 75165
        • ClinPoint Trials
    • Utah
      • Bountiful, Utah, United States, 84010
        • Val Hansen
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development
      • Draper, Utah, United States, 84020
        • J. Lewis research Inc./ Foothill Family Clinic South
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • Riverton, Utah, United States, 84065
        • Granger Medical Clinic-Riverton
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis research Inc./ Foothill Family Care
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis research Inc./ Foothill Family Clinic South
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Inc/ FirstMed East
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research Inc./Jordan River Family Medicine
    • Virginia
      • Arlington, Virginia, United States, 22203
        • Millennium Clinical Trials, LLC
  • Vietnam
      • Hanoi, Vietnam, 100000
        • Bach Mai Hospital
      • Hanoi, Vietnam, 100000
        • National Hospital for Tropical Diseases
      • Ho Chi Minh, Vietnam
        • Nguyen Tri Phuong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm 1 (pimodivir + SOC treatment)
Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).
Drug: Pimodivir 600 mg
Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6).
Other Names:
  • JNJ-63623872
Other: SOC Treatment
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
Placebo Comparator: Treatment Arm 2 (placebo + SOC treatment)
Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Other: SOC Treatment
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
Drug: Placebo
Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Up to Day 28
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Up to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Hospitalized After Treatment Initiation
Time Frame: Up to Day 28
The number of participants hospitalized after treatment initiation were reported.
Up to Day 28
Viral Load Over Time
Time Frame: Baseline, Day 3, 6, 10, 14
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Baseline, Day 3, 6, 10, 14
Number of Participants With Emergence of Viral Resistance to Pimodivir
Time Frame: Up to Day 28
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Up to Day 28
Plasma Concentration of Pimodivir
Time Frame: Day 3, 6, 7
Plasma concentration of Pimodivir was reported.
Day 3, 6, 7
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to Day 28
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to Day 28
Number of Participants With Clinically Significant Changes in Laboratory Tests
Time Frame: Up to Day 28
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
Up to Day 28
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Time Frame: Up to Day 28
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
Up to Day 28
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Up to Day 28
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
Up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2018

Primary Completion (Actual)

May 28, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108400
  • 2017-002217-59 (EudraCT Number)
  • 63623872FLZ3002 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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