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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04056611




Registration number
NCT04056611
Ethics application status
Date submitted
13/08/2019
Date registered
14/08/2019
Date last updated
24/06/2020

Titles & IDs
Public title
Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who Are Infected With Respiratory Syncytial Virus (RSV)
Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract
Secondary ID [1] 0 0
53718678RSV2005
Secondary ID [2] 0 0
CR108662
Universal Trial Number (UTN)
Trial acronym
FREESIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678 250 mg
Treatment: Drugs - Placebo
Treatment: Drugs - JNJ-53718678 125 mg

Experimental: Adult cohort: JNJ-53718678 or Placebo - Participants greater than or equal to (>=) 18 to less than or equal to (<=) 75 years of age will receive 250 milligram (mg) JNJ-53718678 twice daily (bid) for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg once daily (qd) for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.

Experimental: Adolescent cohort: JNJ-53718678 or Placebo - Participants >=13 to <18 years of age will receive 250 mg JNJ-53718678 bid for 21 days (without coadministration with moderate or strong CYP3A4 inhibitors), or 125 mg JNJ-53718678 bid for 21 days (coadministered with moderate or strong CYP3A4 inhibitors with the exception of posaconazole), or 125 mg qd for 21 days (when coadministered with posaconazole), or matching placebo for 21 days.


Treatment: Drugs: JNJ-53718678 250 mg
JNJ-53718678 250 mg will be administered orally.

Treatment: Drugs: Placebo
Matching placebo will be administered orally.

Treatment: Drugs: JNJ-53718678 125 mg
JNJ-53718678 125 mg will be administered orally.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Participants who Develop Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI) - The proportion of participants who develop RSV LRTI through Visit Day 28 per the Endpoint Adjudication Committee (EAC) assessment will be reported.
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [1] 0 0
Proportion of Participants who Develop RSV-associated Lower Respiratory Tract Complication (LRTC) - The proportion of participants who develop RSV-associated LRTC through Visit Day 28 per the EAC's assessment will be reported.
Timepoint [1] 0 0
Up to Day 28
Secondary outcome [2] 0 0
Number of Participants with Adverse Events (AEs) - An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Timepoint [2] 0 0
Up to 49 days
Secondary outcome [3] 0 0
Percentage of Participants with Abnormal Clinical Laboratory Findings - Percentage of participants with abnormal clinical laboratory findings will be reported.
Timepoint [3] 0 0
Up to 49 days
Secondary outcome [4] 0 0
Percentage of Participants with Abnormal Electrocardiograms (ECGs) Findings - Percentage of participants with abnormal ECGs findings will be reported.
Timepoint [4] 0 0
Up to 49 days
Secondary outcome [5] 0 0
Percentage of Participants with Abnormal Vital Signs Findings - Percentage of participants with abnormal vital signs findings will be reported.
Timepoint [5] 0 0
Up to 49 days
Secondary outcome [6] 0 0
Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment - The proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Timepoint [6] 0 0
Up to 49 days
Secondary outcome [7] 0 0
Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death, (all-cause Mortality) - Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death, (all-cause mortality) will be reported.
Timepoint [7] 0 0
Up to 49 days
Secondary outcome [8] 0 0
Proportion of Participants Progressing to Death (All-cause Mortality), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment - Proportion of participants progressing to death (all-cause mortality), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Timepoint [8] 0 0
Up to 49 days
Secondary outcome [9] 0 0
Proportion of Participants Progressing to Death (All-cause Mortality) - Proportion of participants progressing to death (all-cause mortality) will be reported.
Timepoint [9] 0 0
Up to 1 year
Secondary outcome [10] 0 0
Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive), in Participants who Develop RSV LRTI or RSV-associated LRTC per the EAC's Assessment - Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive), in participants who develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Timepoint [10] 0 0
Up to 49 days
Secondary outcome [11] 0 0
Proportion of Participants Progressing to Respiratory Failure (of any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) - Proportion of participants progressing to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) will be reported.
Timepoint [11] 0 0
Up to 49 days
Secondary outcome [12] 0 0
Number of Supplemental Oxygen (O2) Free Days Through Day 28 - Number of supplemental O2 free days will be reported.
Timepoint [12] 0 0
Through Day 28
Secondary outcome [13] 0 0
Incidence of Supplemental Oxygen Requirement - Incidence of supplemental oxygen requirement in participants will be reported.
Timepoint [13] 0 0
Up to 28 days
Secondary outcome [14] 0 0
Duration of Supplemental Oxygen - Duration of supplemental oxygen requirement in participants will be reported.
Timepoint [14] 0 0
Up to 28 days
Secondary outcome [15] 0 0
Change from Baseline in Respiratory Rate - Change from baseline in respiratory rate as measured by the investigator during scheduled visits will be reported.
Timepoint [15] 0 0
Baseline up to 49 days
Secondary outcome [16] 0 0
Change from Baseline in Heart Rate - Change from baseline in heart rate as measured by the investigator during scheduled visits will be reported.
Timepoint [16] 0 0
Baseline up to 49 days
Secondary outcome [17] 0 0
Change from Baseline in Peripheral Capillary Oxygen Saturation (SpO2) - Change from baseline in SpO2 as measured by the investigator during scheduled visits will be reported.
Timepoint [17] 0 0
Baseline up to 49 days
Secondary outcome [18] 0 0
Change from Baseline in Body Temperature - Change from baseline in body temperature as measured by the investigator during scheduled visits will be reported.
Timepoint [18] 0 0
Baseline up to 49 days
Secondary outcome [19] 0 0
Proportion of Participants Hospitalized (of Participants who Were not Hospitalized at Baseline) - Proportion of participants hospitalized (of participants who were not hospitalized at baseline) will be reported.
Timepoint [19] 0 0
Up to 1 year
Secondary outcome [20] 0 0
Proportion of Participants Re-hospitalized - Proportion of participants re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline, required hospitalization, and were discharged during the study) will be reported.
Timepoint [20] 0 0
Up to 1 year
Secondary outcome [21] 0 0
Total Length of Hospital Stay - Total length of hospital stay (time in hospital from first dosing) will be reported.
Timepoint [21] 0 0
Up to 49 days
Secondary outcome [22] 0 0
Total Time in the Intensive Care Unit (ICU) - Total time in the ICU (time in ICU from first dosing) will be reported.
Timepoint [22] 0 0
Up to 49 days
Secondary outcome [23] 0 0
Incidence of Grade 3 and Grade 4 Adverse Events (AEs) - Incidence of Grade 3 and Grade 4 AEs will be assessed by system organ class where Grade 3: Severe and Grade 4: Life-threatening.
Timepoint [23] 0 0
Up to 49 days
Secondary outcome [24] 0 0
Incidence of Respiratory AEs - Incidence of respiratory AEs will be reported.
Timepoint [24] 0 0
Up to 49 days
Secondary outcome [25] 0 0
Incidence of Thoracic-related AEs - Incidence of thoracic-related AEs will be reported.
Timepoint [25] 0 0
Up to 49 days
Secondary outcome [26] 0 0
Incidence of Antibiotic use in Participants who Develop and in Those who do not Develop RSV LRTI or RSV-Associated LRTC per the EAC's Assessment - Incidence of antibiotic use in participants who develop and in those who do not develop RSV LRTI or RSV-associated LRTC per the EAC's assessment will be reported.
Timepoint [26] 0 0
Up to 49 days
Secondary outcome [27] 0 0
Time to Resolution of Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale - Time to resolution of symptoms, assessed through an instrument for participant-reported symptoms (RiiQ Symptom Scale) will be reported.
Timepoint [27] 0 0
Up to 49 days
Secondary outcome [28] 0 0
Change from Baseline in Severity of Symptoms Reported by Participants in the RiiQ Symptom Scale Through Day 28 - Change from baseline in severity of symptoms reported by participants in the RiiQ symptom scale through Day 28 will be reported.
Timepoint [28] 0 0
Baseline up to Day 28
Secondary outcome [29] 0 0
Time to Resolution of Respiratory Illness as Assessed by Patient Global Impression of Severity (PGI-S) Scale - Time to resolution of respiratory illness, through the PGI-S Scale, will be reported.
Timepoint [29] 0 0
Up to 49 days
Secondary outcome [30] 0 0
Change from Baseline in Patient Global Impression of Health (PGI-H) Scale Through Day 28 - Change from baseline in PGI-H scale through Day 28 will be reported.
Timepoint [30] 0 0
Baseline up to Day 28
Secondary outcome [31] 0 0
Change from Baseline in Patient Global Impression of Change (PGI-C) Scale Through Day 28 - Change from baseline in PGI-C scale through Day 28 will be reported.
Timepoint [31] 0 0
Baseline up to Day 28
Secondary outcome [32] 0 0
Area Under the Plasma Concentration-time Curve from Time Zero to 24 Hours Postdose (AUC [0-24]) of JNJ-53718678 - AUC (0-24h) is defined as area under the plasma concentration-time curve from time 0 to 24 hours postdose.
Timepoint [32] 0 0
Up to 24 hours postdose (on Days 1 and 8)
Secondary outcome [33] 0 0
Trough Plasma Concentration (Ctrough) of JNJ-53718678 - Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
Timepoint [33] 0 0
Predose on Days 1 and 8
Secondary outcome [34] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678 - Cmax is defined as the maximum observed plasma concentration of JNJ-53718678 in the dosing interval.
Timepoint [34] 0 0
Day 1
Secondary outcome [35] 0 0
Association of Plasma Concentration-time Data of JNJ-53718678 and Antiviral Activity - The potential association of plasma concentration-time data of JNJ-53718678 with antiviral activity (RSV viral kinetics) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Timepoint [35] 0 0
Up to 49 days
Secondary outcome [36] 0 0
Association of Plasma Concentration-time Data of JNJ-53718678 and Safety Parameters - The potential association of plasma concentration-time data of JNJ-53718678 with selected safety (including AEs and laboratory abnormalities) parameters will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Timepoint [36] 0 0
Up to 49 days
Secondary outcome [37] 0 0
Association of Plasma Concentration-time Data of JNJ-53718678 and Clinical Outcomes - The potential association of plasma concentration-time data of JNJ-53718678 with clinical outcomes (proportion of participants developing LRTI) will be analyzed. Association will be analyzed using (non)-linear mixed-effects models in a tabular and/or graphical display.
Timepoint [37] 0 0
Up to 49 days
Secondary outcome [38] 0 0
RSV Viral Load and Change from Baseline Over Time - RSV viral load and change from baseline over time will be measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in the mid-turbinate nasal swab specimens.
Timepoint [38] 0 0
Baseline up to Day 28
Secondary outcome [39] 0 0
RSV Viral Load AUC from Immediately Prior to First Dose of Study Drug (Baseline) Through Days 8, 11, 15, 22 and 28 - RSV viral load AUC will be determined by quantitative qRT-PCR assay of nasal swabs.
Timepoint [39] 0 0
Baseline up to Days 8, 11, 15, 22 and 28
Secondary outcome [40] 0 0
Time to Undetectable RSV Viral Load - Time to undetectable RSV viral load (per the detection limit of the assay used in the study) will be reported.
Timepoint [40] 0 0
Up to 49 days
Secondary outcome [41] 0 0
Proportion of Participants with Undetectable RSV Viral Load at Each Timepoint - Proportion of participants with undetectable RSV viral load at each time point throughout the study will be reported.
Timepoint [41] 0 0
Up to 49 days
Secondary outcome [42] 0 0
Change from Baseline for the Health-related Quality of Life (HRQOL) as Assessed by 5-level EuroQol 5-Dimension (EQ-5D-5L) Through Day 28 - Change from baseline for the HRQOL assessment as assessed through the EQ-5D-5L through Day 28 will be reported.
Timepoint [42] 0 0
Baseline up to Day 28
Secondary outcome [43] 0 0
Change from Baseline for the HRQOL as Assessed by RiiQ Impact Scales Through Day 28 - Change from baseline for the HRQOL assessment as assessed through RiiQ impact scales through Day 28 will be reported.
Timepoint [43] 0 0
Baseline up to Day 28
Secondary outcome [44] 0 0
Change from Baseline in the RSV F Gene Sequence - Change from baseline in the RSV F gene sequence will be reported.
Timepoint [44] 0 0
Baseline up to 49 days

Eligibility
Key inclusion criteria
- Received an autologous or allogeneic hematopoietic stem cell transplant (HSCT) using
any conditioning regimen

- Absolute lymphocyte count (ALC) less than (<) 1,000 cells/microliter (mL)

- Participant has laboratory confirmed RSV diagnosis within 48 hours of randomization

- New onset of at least 1 of the following respiratory symptoms within 4 days prior to
the anticipated start of dosing nasal congestion, rhinorrhea, cough or pharyngitis
(sore throat), and/or worsening of one of these chronic (associated with previously
existing diagnosis, example, chronic rhinorrhea, seasonal allergies, chronic lung
disease) respiratory symptoms within 4 days prior to the anticipated start of dosing

- Peripheral capillary oxygen saturation (SpO2) greater than or equal to (>=) 92 percent
(%) on room air
Minimum age
13 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Admitted to the hospital primarily for a lower respiratory tract disease of any cause
as determined by the investigator

- Requires supplemental oxygen at Screening or any time between Screening and
randomization

- Documented to be positive for other respiratory viruses (limited to influenza,
parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus)
within 7 days prior to or at the Screening visit, if determined by local SOC testing
(additional testing is not required)

- Clinically significant bacteremia or fungemia within 7 days prior to or at Screening
that has not been adequately treated, as determined by the investigator

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Argentina
State/province [20] 0 0
Bahia Blanca
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad De La Plata
Country [23] 0 0
Argentina
State/province [23] 0 0
Cordoba
Country [24] 0 0
Argentina
State/province [24] 0 0
Florencio Varela
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel de Tucuman
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Gent
Country [29] 0 0
Belgium
State/province [29] 0 0
Leuven
Country [30] 0 0
Belgium
State/province [30] 0 0
Liege
Country [31] 0 0
Belgium
State/province [31] 0 0
Limburg
Country [32] 0 0
Brazil
State/province [32] 0 0
Barretos
Country [33] 0 0
Brazil
State/province [33] 0 0
Belo Horizonte
Country [34] 0 0
Brazil
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Florianopolis
Country [35] 0 0
Brazil
State/province [35] 0 0
Fortaleza
Country [36] 0 0
Brazil
State/province [36] 0 0
Jau
Country [37] 0 0
Brazil
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Nova Lima
Country [38] 0 0
Brazil
State/province [38] 0 0
Porto Alegre
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio de Janeiro
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Paulo
Country [41] 0 0
Brazil
State/province [41] 0 0
São José do Rio Preto
Country [42] 0 0
Brazil
State/province [42] 0 0
São Paulo
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Plovdiv
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Sofia
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Varna
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
France
State/province [50] 0 0
Clamart
Country [51] 0 0
France
State/province [51] 0 0
Montpellier
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France
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Nantes Cedex 1
Country [53] 0 0
France
State/province [53] 0 0
Paris
Country [54] 0 0
France
State/province [54] 0 0
Rouen
Country [55] 0 0
France
State/province [55] 0 0
Suresnes
Country [56] 0 0
France
State/province [56] 0 0
Toulouse
Country [57] 0 0
Germany
State/province [57] 0 0
Leipzig
Country [58] 0 0
Germany
State/province [58] 0 0
Mainz
Country [59] 0 0
Germany
State/province [59] 0 0
Munster
Country [60] 0 0
Israel
State/province [60] 0 0
Haifa
Country [61] 0 0
Israel
State/province [61] 0 0
Jerusalem
Country [62] 0 0
Israel
State/province [62] 0 0
Petah Tikva
Country [63] 0 0
Israel
State/province [63] 0 0
Ramat Gan
Country [64] 0 0
Israel
State/province [64] 0 0
Tel Aviv
Country [65] 0 0
Italy
State/province [65] 0 0
Genova
Country [66] 0 0
Italy
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Milano
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Italy
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Roma
Country [68] 0 0
Japan
State/province [68] 0 0
Akita
Country [69] 0 0
Japan
State/province [69] 0 0
Chiba
Country [70] 0 0
Japan
State/province [70] 0 0
Isehara
Country [71] 0 0
Japan
State/province [71] 0 0
Kobe
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Japan
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Kumamoto-City
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Japan
State/province [73] 0 0
Matsumoto
Country [74] 0 0
Japan
State/province [74] 0 0
Nagano
Country [75] 0 0
Japan
State/province [75] 0 0
Nagoya
Country [76] 0 0
Japan
State/province [76] 0 0
Narita
Country [77] 0 0
Japan
State/province [77] 0 0
Nishinomiya
Country [78] 0 0
Japan
State/province [78] 0 0
Okayama
Country [79] 0 0
Japan
State/province [79] 0 0
Osaka-Shi
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Japan
State/province [80] 0 0
Sapporo
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Japan
State/province [81] 0 0
Shibuya
Country [82] 0 0
Japan
State/province [82] 0 0
Tokyo
Country [83] 0 0
Japan
State/province [83] 0 0
Tsukuba
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Seoul
Country [85] 0 0
Malaysia
State/province [85] 0 0
Ampang Jaya
Country [86] 0 0
Malaysia
State/province [86] 0 0
Georgetown
Country [87] 0 0
Malaysia
State/province [87] 0 0
Kuala Lumpur
Country [88] 0 0
Malaysia
State/province [88] 0 0
Petaling Jaya
Country [89] 0 0
Netherlands
State/province [89] 0 0
Leiden
Country [90] 0 0
Netherlands
State/province [90] 0 0
Utrecht
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Ekaterinburg
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Kirov
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moscow
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Samara
Country [95] 0 0
Russian Federation
State/province [95] 0 0
St Petersburg
Country [96] 0 0
Russian Federation
State/province [96] 0 0
St. Petersburg
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid
Country [99] 0 0
Spain
State/province [99] 0 0
Salamanca
Country [100] 0 0
Spain
State/province [100] 0 0
Santander
Country [101] 0 0
Spain
State/province [101] 0 0
Sevilla
Country [102] 0 0
Spain
State/province [102] 0 0
Valencia
Country [103] 0 0
Sweden
State/province [103] 0 0
Malmö
Country [104] 0 0
Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Switzerland
State/province [105] 0 0
Basel
Country [106] 0 0
Switzerland
State/province [106] 0 0
Bern
Country [107] 0 0
Taiwan
State/province [107] 0 0
Kaohsiung
Country [108] 0 0
Taiwan
State/province [108] 0 0
Taichung
Country [109] 0 0
Taiwan
State/province [109] 0 0
Tainan
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taipei
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Birmingham
Country [112] 0 0
United Kingdom
State/province [112] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Sciences Ireland UC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effect of JNJ-53718678 on the development of
respiratory syncytial virus (RSV) lower respiratory tract infection (LRTIs) in adult
hematopoietic stem cell transplant (HSCT) recipients with RSV upper RTI.
Trial website
https://clinicaltrials.gov/show/NCT04056611
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Janssen Sciences Ireland UC Clinical Trial
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Janssen Sciences Ireland UC
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Contact person for public queries
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Study Contact
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844-434-4210
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JNJ.CT@sylogent.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04056611