Clinical trial NCT03656510: Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
Official title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-04
Enrollment: 246
Sex: ALL
Minimum age (years): 28
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants \[Cohort 1\] or outpatients \[Cohort 2\]).

Detailed description: JNJ-53718678 is an investigational respiratory syncytial virus (RSV) specific fusion inhibitor and is under development for the treatment of RSV infection, which results in an upper and/or lower respiratory tract illness. The primary hypothesis of this study is that JNJ-53718678 has antiviral activity against RSV (that is, results in a decrease in RSV nasal viral load from immediately prior to first dose of study drug until Day 5). This will be assessed by a positive dose-response relationship of JNJ-53718678 compared to placebo. Besides the RSV nasal viral load through day 5, other timepoints will also be evaluated as well as other nasal viral load related parameters. In addition, the evolution of signs and symptoms of RSV disease will be evaluated. Participants' safety will be monitored throughout the study by evaluating the occurrence and severity of adverse events and by laboratory and electrocardiogram measurements. Study participants will be identified when they are hospitalized or expected to be hospitalized within 24 hours after presentation to the hospital (Cohort 1) or present for medical care as outpatients (Cohort 2) with symptoms of an acute respiratory illness supporting a diagnosis of RSV infection. Eligible participants will be randomized 1:1:1 to receive either a low or a high dose of JNJ 53718678 or placebo and will be receiving study treatment for 7 days. They will be followed up for 3 weeks after the last dose. The total study duration for each participant will be approximately 29 days.

Eligibility criteria: Inclusion Criteria:

* Informed consent form (ICF) must be given
* Laboratory diagnosis of respiratory syncytial virus (RSV) infection
* The participant has an acute respiratory illness
* The time of onset of RSV symptoms to the anticipated time of randomization must be less than or equal to (\<=) 5 days
* Except for the RSV-related illness, the Participant must be medically stable in case of allowed co-morbid conditions
* The participant must have been assessed per local public health practice and considered not to have Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during this respiratory infection

Exclusion Criteria:

* The participant is less than (\<) 3 months postnatal age at screening and was born prematurely (i.e, \<37 weeks and 0 days of gestation) OR if the participant weighs \<2.4 kilogram (kg) or greater than (\>) 16.8 kg
* Participant is considered by the investigator to be immunocompromised within the past 12 months
* Participant unwilling or unable to undergo mid-turbinate nasal swab procedures
* Participant is receiving chronic home oxygen therapy at screening
* Participant has other clinically significant abnormal electrocardiogram (ECG) findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening
* The participant has a QTcF interval greater than (\>)450 millisecond (ms) per the machine read (mean of triplicate) parameter result confirmed by repeat triplicate ECG recording during screening

Primary outcomes:
measure: Respiratory Syncytial Virus (RSV) Viral Load Area Under Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 (AUC[Day 5])
timeFrame: Baseline through Day 5
Secondary outcomes:
measure: RSV Viral Load Over Time
timeFrame: Baseline, Days 3, 5, 8, 14, and 21
measure: Change From Baseline in RSV Viral Load Over Time
timeFrame: Baseline up to Days 3, 5, 8, 14, and 21
measure: Least Squares (LS) Mean RSV Viral Load on Days 3, 8 and 14
timeFrame: Baseline through Days 3, 8, and 14
measure: Time to Undetectable RSV Viral Load
timeFrame: Up to Day 21
measure: Percentage of Participants With Undetectable RSV Viral Load at Each Timepoint Throughout the Study
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcomes Rating System (PRESORS) Scores
timeFrame: Baseline up to Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Clinician PRESORS Score
timeFrame: Baseline, up to Days 3, 5, 8, 14 and 21
measure: Time to Resolution of RSV Symptoms Based on PRESORS Caregiver (ObsRO)
timeFrame: Up to Day 21
measure: Time to Improvement on Overall Health
timeFrame: Up to Day 21
measure: Percentage of Participants by Status of RSV Symptoms Based on PRESORS Caregiver (ObsRO) General Question Over Time
timeFrame: Baseline, Days 3, 5, 8, 14, and 21
measure: Percentage of Participants by Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
timeFrame: Baseline, Days 3, 5, 8, 14, and 21
measure: Percentage of Participants With Worsening or Improvement Status of RSV Disease
timeFrame: Days 14 and 21
measure: Percentage of Participants by Return to Pre-RSV Disease Health Status Assessment Based on PRESORS Caregiver (ObsRO) General Question Over Time
timeFrame: Baseline, Days 3, 5, 8, 14, and 21
measure: Respiratory Rate (RR) Over Time
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Respiratory Rate
timeFrame: Baseline to Days 3, 5, 8, 14 and 21
measure: Heart Rate Over Time
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Heart Rate
timeFrame: Baseline to Days 3, 5, 8, 14 and 21
measure: Body Temperature Over Time
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Body Temperature
timeFrame: Baseline to Days 3, 5, 8, 14 and 21
measure: Peripheral Capillary Oxygen Saturation (SpO2) Over Time
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Change From Baseline in Peripheral Capillary Oxygen Saturation (SpO2)
timeFrame: Baseline to Days 3, 5, 8, 14, and 21
measure: Percentage of Participants Who Required (re)Hospitalization During Treatment and Follow-up
timeFrame: Up to Day 28
measure: Cohort 1: Time to Return to Age-adjusted Normal Values for Vital Signs
timeFrame: Up to Day 28
measure: Cohort 1: Time to Discharge From Hospital
timeFrame: Up to Day 28
measure: Cohort 1: Percentage of Participants Who Required Admission to the Intensive Care Unit (ICU)
timeFrame: Up to Day 21
measure: Cohort 1: Duration of ICU Stay
timeFrame: Up to Day 21
measure: Cohort 1: Time to Clinical Stability Evaluated by the Investigator
timeFrame: Up to Day 21
measure: Cohort 1: Percentage of Participants Who Required Supplemental Oxygen
timeFrame: Up to Day 21
measure: Cohort 1: Duration of Supplemental Oxygen
timeFrame: Up to Day 28
measure: Cohort 1: Percentage of Participants Who Required Non-invasive Mechanical Ventilation Support
timeFrame: Up to Day 21
measure: Cohort 1: Percentage of Participants Who Required Invasive Mechanical Ventilation Support
timeFrame: Up to Day 21
measure: Cohort 1: Percentage of Participants Who Required Non-invasive Non-mechanical Ventilation Support
timeFrame: Up to Day 21
measure: Cohort 1: Duration of Non-invasive Ventilation Support
timeFrame: Up to Day 21
measure: Cohort 1: Duration of Invasive Ventilation Support
timeFrame: Up to Day 21
measure: Cohort 1: Time to End of Supplemental Oxygen up to 72 Hours From First Hospital Discharge
timeFrame: Up to end of supplemental oxygen including supplemental oxygen within 72 hours after first hospital discharge (up to Day 28)
measure: Cohort 1: Percentage of Participants Who Needed Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube
timeFrame: Up to Day 28
measure: Percentage of Participants With Adverse Events
timeFrame: Up to Day 28
measure: Percentage of Participants With Abnormal Laboratory Findings
timeFrame: Up to Day 28
measure: Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
timeFrame: Up to Day 28
measure: Percentage of Participants With Categorized Change From Baseline in ECG Parameters (QT, QTcB, QTcF)
timeFrame: Baseline to Day 28
measure: Percentage of Participants With Vital Signs Abnormalities
timeFrame: Up to Day 28
measure: Cohort 1: Area Under the Plasma Concentration-Time Curve From Timepoint 0 Hours Until 24 Hours Post Dose (AUC[0-24 Hours])
timeFrame: 0 to 24 hours post dose on Days 1 and 7
measure: Cohort 1: Maximum Plasma Concentration (Cmax) of JNJ-53718678
timeFrame: Days 1 and 7
measure: Cohort 1: Trough Plasma Concentration (Ctrough) of JNJ-53718678
timeFrame: Days 1 and 7
measure: Cohort 2: Plasma Concentration of JNJ-53718678
timeFrame: Once daily dosing: Day 3 and Day 8 pre- or post-dose. Twice daily dosing: Day 1 at least 1 hour post-dose, and Days 3 or 5 (combined in one timepoint) at least 4 hours after morning dose but prior to evening dose
measure: Percentage of Participants With Medical Resource Utilization (MRU)
timeFrame: Up to Day 28
measure: Percentage of Participants With Acceptability and Palatability of the JNJ-53718678 Formulation as Assessed by Parent(s)/Caregiver(s)
timeFrame: Day 8
measure: Number of Participants With Emerging Variations in the Viral Genome Potentially Associated With Resistance to JNJ-53718678
timeFrame: Up to Day 21
Other outcomes:
Locations:
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Ventura
country: United States
facility: FOMAT Medical Research
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Blackfoot
country: United States
facility: Elite Clinical Trials
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: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Bridgeton
country: United States
facility: Craig A. Spiegel, MD
state: Missouri
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)
state: New York
city: Oklahoma City
country: United States
facility: Santiago Reyes, MD
state: Oklahoma
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Bahía Blanca
country: Argentina
facility: Hospital Italiano Regional Del Sur
city: Buenos Aires
country: Argentina
facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
city: City of Buenos Aires
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: City of Buenos Aires
country: Argentina
facility: Hospital Pedro de Elizalde
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad De La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de UMCB
city: San Miguel de Tucumán
country: Argentina
facility: Hospital del Niño Jesús
city: Anderlecht
country: Belgium
facility: ULB Hôpital Erasme
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Liège
country: Belgium
facility: C.H.R. Citadelle
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Botucatu
country: Brazil
facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
city: Campinas
country: Brazil
facility: Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
city: Curitiba
country: Brazil
facility: Nucleo de Pesquisa do Hospital Pequeno Princípe
city: Fortaleza
country: Brazil
facility: Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
city: Passo Fundo
country: Brazil
facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Fundacao Jose Luiz Egydio Setubal
city: Sorocaba
country: Brazil
facility: CMPC - Consultoria Médica e Pesquisa Clínica
city: Votuporanga
country: Brazil
facility: Santa Casa de Misericórdia de Votuporanga
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: UMHAT 'Sveti Georgi'-Plovdiv
city: Ruse
country: Bulgaria
facility: UMHAT 'Kanev' EAD
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Sofia
country: Bulgaria
facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
city: Sofia
country: Bulgaria
facility: UMHAT 'Aleksandrovska' EAD
city: Sofia
country: Bulgaria
facility: SHATCD 'Prof. Ivan Mitev' EAD
city: Caen
country: France
facility: CHU de Caen
city: CLAMART Cedex
country: France
facility: Hopital Antoine Beclere
city: Montpellier
country: France
facility: CHU de Montpellier - Arnaud de Villeneuve
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Nice
country: France
facility: Hopitaux pediatriques CHU Lenval
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Bramsche
country: Germany
facility: Kinderarztpraxis Bramsche
city: Hürth
country: Germany
facility: Hürthpark Kinder & Jugendärzte
city: Schönau am Königssee
country: Germany
facility: Praxiszentrum Triftplatz
city: Wolfsburg
country: Germany
facility: Kinderärztliche Gemeinschaftspraxis
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
city: Budapest
country: Hungary
facility: Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ,Infektológiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: Futurenest Klinikai Kutato Kft.
city: Nagykanizsa
country: Hungary
facility: Kanizsai Dorottya Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Székesfehérvár
country: Hungary
facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
city: Veszprém
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
city: Milano
country: Italy
facility: Dipartimento di Pediatria dell'Ospedale Luigi Sacco
city: Milan
country: Italy
facility: Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Department of Pediatrics University of Pavia, Policlinico San Matteo
city: Ponderano
country: Italy
facility: Ospedale degli Infermi
city: Bunkyo-Ku
country: Japan
facility: Hosaka Kodomo Clinic
city: Fujieda
country: Japan
facility: Kobayashi Pediatric Clinic
city: Fukui City
country: Japan
facility: Fukui-ken Saiseikai Hospital
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
city: Hatsukaichi
country: Japan
facility: Tanabe Pediatrics Clinic
city: Hioki
country: Japan
facility: Kagoshima Children's Hospital
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
city: Hiroshima
country: Japan
facility: Shirao Clinic of Pediatrics and Pediatric Allergy
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
city: Nagoya
country: Japan
facility: Kojunkai Daido Clinic
city: Nagoya
country: Japan
facility: Kojunkai Daido Hospital
city: Oita
country: Japan
facility: National Hospital Organization Beppu Medical Center
city: Okayama City
country: Japan
facility: Momotaro Clinic
city: Saitama
country: Japan
facility: National Hospital Organization Saitama National Hospital
city: Sapporo
country: Japan
facility: KKR Sapporo Medical Center
city: Setagaya-ku
country: Japan
facility: Tsuda Pediatrics Clinic
city: Tokyo
country: Japan
facility: Okawa Children & Family Clinic
city: Tokyo
country: Japan
facility: INAMI Pediatric clinic
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Miri
country: Malaysia
facility: Hospital Miri
city: Pusat Bandar Kangar
country: Malaysia
facility: Hospital Tuanku Fauziah
city: Sibu
country: Malaysia
facility: Hospital Sibu
city: Benito Juarez
country: Mexico
facility: RM Pharma Specialists
city: Ciudad De Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
city: Coyoacan
country: Mexico
facility: Instituto Nacional de Pediatría
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Bydgoszcz
country: Poland
facility: Osrodek Badan Klinicznych In-Vivo Sp. z o.o.
city: Debica
country: Poland
facility: Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej
city: Leczna
country: Poland
facility: NZOZ Salmed
city: Rabka-Zdroj
country: Poland
facility: Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii
city: Tarnow
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.
city: Trzebnica
country: Poland
facility: Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hospital #1 Of The Moscow City Health Department
city: Odintsovo
country: Russian Federation
facility: OOO MDP-Medical Group
city: Perm
country: Russian Federation
facility: City Children Clinical Outpatient Clinic #5
city: St. Petersburg
country: Russian Federation
facility: OOO 'Medical Technologies'
city: St. Petersburg
country: Russian Federation
facility: Children Outpatient Clinic 45 Of Nevskiy Region
city: St. Petersburg
country: Russian Federation
facility: OOO 'Arsvite North-West'
city: St. Petersburg
country: Russian Federation
facility: LLC Pitercliniсa
city: St. Petersburg
country: Russian Federation
facility: LLC Kurator
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Ufa
country: Russian Federation
facility: Bashkir State Medical University
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl State Medical University Based On Children Polyclinics #5
city: Bellville
country: South Africa
facility: Tygrberg Hospital
city: Bloemfontein
country: South Africa
facility: Josha Research
city: Pretoria
country: South Africa
facility: VX Pharma
city: Wynberg
country: South Africa
facility: Two Military Hospital
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Burgos
country: Spain
facility: Hosp. Univ. de Burgos
city: Getafe
country: Spain
facility: Hosp. Univ. de Getafe
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Majadahonda
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Malaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Mostoles
country: Spain
facility: Hosp. Puerta Del Sur
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Malmö
country: Sweden
facility: Barn- Och Ungdomsmedicin
city: Stockholm
country: Sweden
facility: Sachsska barn-och ungdomssjukhuset
city: Stockholm
country: Sweden
facility: Astrid Lindgrens barnsjukhus Solna
city: Hsinchu
country: Taiwan
facility: Hsinchu MacKay Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital- Linkou
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
city: Bangkok
country: Thailand
facility: Tropical Medicine Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Chiang Mai
country: Thailand
facility: Research Institute for Health Sciences
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty Balcali Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Sarıyer
country: Turkey
facility: Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: Poole
country: United Kingdom
facility: The Adam Practice
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: