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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) (FREESIA)

Primary Purpose

Respiratory Syncytial Virus Infections

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

JNJ-53718678 250 mg

Placebo

JNJ-53718678 125 mg

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

Ronald Reagan UCLA Medical Center
Henry Ford Hospital - Hematology/oncology
University Of Minnesota
Northwell Health Cancer Institute
Weill Cornell Medical College
University Hospitals Cleveland Medical Center
Fox Chase Cancer Center
Baylor Scott & White Research Institute
MD Anderson Cancer Center - University of Texas
Hospital Español De Bahia Blanca
Hospital Italiano de La Plata
Sanatorio Allende
Hospital Privado-Universitario de Cordoba
Clinica Mayo de UMCB
Peter MacCallum Cancer Centre
Royal Melbourne Hospital
Westmead Hospital
AZ Sint-Jan
Jules Bordet Institute
UZ Brussel
UZ Gent
UZ Leuven
CHU de Liège
Jessa Ziekenhuis
Fundacao Pio XII
Universidade Federal De Minas Gerais - Hospital das Clínicas
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Universidade Federal do Ceara - Hospital Universitario Walter Cantidio
Fundacao Doutor Amaral Carvalho
Hospital das Clinicas de Porto Alegre
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Real e Benemérita Associação Portuguesa de Beneficência
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Fundação Antônio Prudente - A.C. Camargo Cancer Center
UMHAT 'Sveti Georgi'-Plovdiv
Specialized Hospital for Active Treatment of Haematologic Diseases
Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD
Hôpital d'Instruction des Armées Percy
Institut Universitaire du Cancer Toulouse - Oncopole
Rambam Medical Center
Hadassah Medical Center
Sheba Medical Center
Sourasky (Ichilov) Medical Center
Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele
Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore
Akita University Hospital
Chiba University Hospital
Tokai University Hospital
Japanese Red Cross Society Nagano Hospital
Okayama University Hospital
The Catholic University of Korea, Seoul St. Mary's Hospital
Hospital Ampang
Penang General Hospital
University Malaya Medical Centre
Sunway Medical Centre
Leiden University Medical Center
Hosp. Univ. Vall D Hebron
Hosp. de la Santa Creu i Sant Pau
Hosp. Gral. Univ. Gregorio Marañon
Hosp. Univ. 12 De Octubre
Hosp. Clinico Univ. de Salamanca
Hosp. Univ. Marques De Valdecilla
Hosp. Virgen Del Rocio
Skanes universitetssjukhus
Kaohsiung Medical University Hospital
China Medical University Hospital
National Cheng Kung University Hospital
National Taiwan University Hospital
Kings College Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Adult cohort: JNJ-53718678 or Placebo

Adolescent cohort: JNJ-53718678 or Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

Percentage of participants who developed RSV LRTI was assessed. RSV LRTI was defined as the development of a lower respiratory sign or symptom (including decrease in oxygen saturation or increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, worsening cough) and positive RSV test from lower respiratory tract sample (example [eg], sputum, induced sputum, bronchoalveolar lavage (BAL), lung biopsy, or autopsy specimen) within +-4 days of a new chest image finding, compared to baseline, consistent with a LRTI; OR positive RSV test from lower respiratory tract sample (eg, sputum, induced sputum, BAL, lung biopsy, or autopsy specimen) only; OR positive RSV test from upper respiratory tract sample within ±4 days of a new chest image finding, compared to baseline, consistent with a RSV LRTI as determined by the Endpoint Adjudication Committee (EAC).

Secondary Outcome Measures

Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)

Percentage of participants who developed RSV-associated LRTC was assessed. RSV-associated LRTC defined as development of lower respiratory sign/symptom (includes decrease in oxygen saturation/increase in supplemental oxygen to maintain oxygen saturation, wheezing, rhonchi, rales, dyspnea, tachypnea, and worsening cough) and met 1 of following subcategories determined by EAC: a) RSV LRTI, b) secondary bacterial LRTI (positive specimen for clinically significant bacterium within 4 days of new chest image finding, compared to baseline, consistent with LRTI), c) secondary LRTI due to unusual pathogens (positive specimen for clinically significant unusual organism within 4 days of new chest image finding, compared to baseline, consistent with LRTI), d) secondary LRTC of unknown etiology (new chest image finding than baseline, consistent with LRTI, inflammatory process/ some other clinically significant pulmonary process which were absent within 4 days of new chest image finding).

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the intervention. Any AE which occurred post first dose administration of study drug up to the end of study (EOS) (that is, Day 49) was considered as treatment-emergent.

Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings

Percentage of participants with greater than or equal to (>=) Grade 3 treatment-emergent laboratory abnormalities (platelet count decreased, glucose increase) was assessed in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to end of study (that is, Day 49).

Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings

Percentage of participants with clinically significant abnormalities in ECG findings was assessed in this outcome measure. Various ECG variables assessed were heart rate: abnormally low (<= 45 beats per minute [bpm]), abnormally high (>= 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec), QT interval and corrected QT (QTcF; according to Fridericia's formula) interval (>450 msec, >480 msec, or >500 msec, increases from baseline >30 msec or >60 msec.)

Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings

Percentage of participants with abnormal vital signs findings was assessed. Abnormal vital parameters included pulse rate: abnormally low <=45 bpm, abnormally high >=120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 Millimeter of mercury (mmHg), Grade 1 (mild): > 90 mmHg - < 100 mmHg, Grade 2 (moderate): >= 100 mmHg to <110 mmHg, Grade 3 (severe): >=110 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1: >90 mmHg to <100 mmHg, Grade 2: >=100 mmHg to <110 mmHg, Grade 3: >=110 mmHg; Respiratory rate- Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): >25 breaths per minute, Grade 4 (potentially life threatening): intubation; Temperature: abnormally high >38.0 degree celsius. Vital signs abnormalities reported for at least 1 participant were reported in this outcome measure. Treatment-emergent: any abnormality occurred post first dose of study drug up to EOS (that is, Day 49).

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death (all-cause mortality) was assessed.

Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment

Percentage of participants who progressed to death (all-cause mortality) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Percentage of Participants Who Progressed to Death (All-cause Mortality)

Percentage of participants who progressed to death (all-cause mortality) was assessed.

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.

Number of Supplemental Oxygen Free Days

Number of supplemental oxygen free days was assessed. The number of supplemental oxygen free days was the number of days the participants did not receive/require supplemental oxygen during the first 28 days post treatment.

Percentage of Participants With Treatment-emergent Oxygen Supplementation

Percentage of participants who required treatment-emergent oxygen supplementation (e.g., supplemental oxygen, noninvasive pressure ventilation, invasive mechanical ventilation [tracheal tube, laryngeal mask or tracheostomy]). Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.

Respiratory Rate Over Time

Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Heart Rate Over Time

Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Peripheral Capillary Oxygen Saturation (SpO2) Over Time

Peripheral capillary oxygen saturation (SpO2) over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Body Temperature Over Time

Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)

Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.

Percentage of Participants Who Were Re-hospitalized

Percentage of participants who were re-hospitalized (of participants who were hospitalized at baseline and discharged during the study and of participants who were not hospitalized at baseline and required hospitalization and were discharged during the study) was assessed in this outcome measure.

Duration of Hospital Stay

Duration (in days) of hospital stay was assessed.

Duration of Intensive Care Unit (ICU) Stay

Duration of ICU stay was assessed. Duration (in hours) was defined as total number of hours a participant was in ICU from first dose of study drug until study termination.

Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily had a causal relationship with the intervention. Participants with Grade 3 or Grade 4 TEAE were assessed in this outcome measure. Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.

Number of Participants With Respiratory Related AEs

Number of participants with respiratory related AEs (respiratory infections) was assessed.

Number of Participants With Thoracic-related AEs

Number of participants with thoracic-related AEs was assessed.

Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment

Number of participants with antibiotic use among those who developed RSV LRTI or RSV-associated LRTC per the EAC's assessment was assessed. Here, '0' in the 'number of participants analyzed' field (N=0) signifies that no participants were available for the analysis because none of the participants developed RSV LRTI or RSV-associated LRTC per the EAC's Assessment.

Plasma Concentration of JNJ-53718678

Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

RSV Viral Load Over Time

RSV viral load (RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints in which individual participant had data were reported.

Full Information

NCT ID

NCT04056611

First Posted

August 13, 2019

Last Updated

March 22, 2023

Sponsor

Janssen Sciences Ireland UC

1. Study Identification

Unique Protocol Identification Number

NCT04056611

Brief 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)

Acronym

FREESIA

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

A strategic decision was made to discontinue the study. The decision was not based on a safety concern.

Study Start Date

December 26, 2019 (Actual)

Primary Completion Date

February 4, 2022 (Actual)

Study Completion Date

February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Sciences Ireland UC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

RSV is recognized as major respiratory pathogen in infants and young children and causes upper and lower respiratory illness among all age groups, often going undiagnosed. Immunocompromised (IC) participants have a reduced ability to combat infection due to an impaired or weakened immune system. Within the IC population, HSCT recipients are generally regarded as having a particularly high risk for more severe disease caused by RSV, representing a substantial unmet need for antiviral treatment of RSV infections in this participant population. JNJ-53718678 is an investigational, potent, small molecule, respiratory syncytial virus (RSV)-specific fusion inhibitor. The study will include a Screening Period (Day -2 to Day 1), a Treatment Period (Day 1 to Day 21), and a Follow-up Period (1 year). Assessments like chest X-ray, pulse/heart rate, respiratory rate, electrocardiogram (ECG), etc will be performed. Safety and efficacy will be assessed through the study. The total study duration for each participant will be approximately 49 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adult cohort: JNJ-53718678 or Placebo

Arm Type

Experimental

Arm Description

Arm Title

Adolescent cohort: JNJ-53718678 or Placebo

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678 250 mg

Intervention Description

JNJ-53718678 250 mg will be administered orally.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo will be administered orally.

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678 125 mg

Intervention Description

JNJ-53718678 125 mg will be administered orally.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)

Description

Time Frame

Up to Day 28

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)

Description

Time Frame

Up to Day 28

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

Up to Day 49

Title

Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings

Description

Time Frame

Up to Day 49

Title

Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings

Description

Time Frame

Up to Day 49

Title

Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings

Description

Time Frame

Up to Day 49

Title

Description

Time Frame

Up to Day 49

Title

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)

Description

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) and/or death (all-cause mortality) was assessed.

Time Frame

Up to Day 49

Title

Percentage of Participants Who Progressed to Death (All-cause Mortality) Among Those Who Developed RSV LRTI or RSV-associated LRTC Per the EAC's Assessment

Description

Time Frame

Up to Day 49

Title

Percentage of Participants Who Progressed to Death (All-cause Mortality)

Description

Percentage of participants who progressed to death (all-cause mortality) was assessed.

Time Frame

Up to Day 49

Title

Description

Time Frame

Up to Day 49

Title

Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)

Description

Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.

Time Frame

Up to Day 49

Title

Number of Supplemental Oxygen Free Days

Description

Time Frame

Through Day 28

Title

Percentage of Participants With Treatment-emergent Oxygen Supplementation

Description

Time Frame

Up to Day 49

Title

Respiratory Rate Over Time

Description

Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Time Frame

Baseline (Day 1), Days 15, 28, and 35

Title

Heart Rate Over Time

Description

Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Time Frame

Baseline (Day 1), Days 15, 28, and 35

Title

Peripheral Capillary Oxygen Saturation (SpO2) Over Time

Description

Peripheral capillary oxygen saturation (SpO2) over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.

Time Frame

Baseline (Day 1), Days 15, 28, and 35

Title

Body Temperature Over Time

Description

Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

Time Frame

Baseline (Day 1), Days 15, 28, and 35

Title

Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)

Description

Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.

Time Frame

Up to Day 49

Title

Percentage of Participants Who Were Re-hospitalized

Description

Time Frame

Up to Day 49

Title

Duration of Hospital Stay

Description

Duration (in days) of hospital stay was assessed.

Time Frame

Up to Day 49

Title

Duration of Intensive Care Unit (ICU) Stay

Description

Duration of ICU stay was assessed. Duration (in hours) was defined as total number of hours a participant was in ICU from first dose of study drug until study termination.

Time Frame

Up to Day 49

Title

Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class

Description

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE did not necessarily had a causal relationship with the intervention. Participants with Grade 3 or Grade 4 TEAE were assessed in this outcome measure. Any AE which occurred post first dose administration of study drug up to the end of study (that is, Day 49) were considered as treatment-emergent.

Time Frame

Up to Day 49

Title

Number of Participants With Respiratory Related AEs

Description

Number of participants with respiratory related AEs (respiratory infections) was assessed.

Time Frame

Up to Day 49

Title

Number of Participants With Thoracic-related AEs

Description

Number of participants with thoracic-related AEs was assessed.

Time Frame

Up to Day 49

Title

Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment

Description

Time Frame

Up to Day 49

Title

Plasma Concentration of JNJ-53718678

Description

Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.

Time Frame

Days 1, 3, 8, 15 and 22

Title

RSV Viral Load Over Time

Description

Time Frame

Baseline (Day 1), Days 15, 28, and 35

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Sciences Ireland UC Clinical Trial

Organizational Affiliation

Janssen Sciences Ireland UC

Official's Role

Study Director

Facility Information:

Facility Name

Ronald Reagan UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Henry Ford Hospital - Hematology/oncology

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

University Of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Northwell Health Cancer Institute

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Baylor Scott & White Research Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

MD Anderson Cancer Center - University of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Hospital Español De Bahia Blanca

City

Bahia Blanca

ZIP/Postal Code

8000

Country

Argentina

Facility Name

Hospital Italiano de La Plata

City

Ciudad De La Plata

ZIP/Postal Code

B1900AX

Country

Argentina

Facility Name

Sanatorio Allende

City

Cordoba

ZIP/Postal Code

X5000JHQ

Country

Argentina

Facility Name

Hospital Privado-Universitario de Cordoba

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Clinica Mayo de UMCB

City

San Miguel de Tucuman

ZIP/Postal Code

T4000IHE

Country

Argentina

Facility Name

Peter MacCallum Cancer Centre

City

Melbourne

ZIP/Postal Code

3000

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Melbourne

ZIP/Postal Code

3050

Country

Australia

Facility Name

Westmead Hospital

City

Westmead

ZIP/Postal Code

2145

Country

Australia

Facility Name

AZ Sint-Jan

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Jules Bordet Institute

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

UZ Brussel

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU de Liège

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Jessa Ziekenhuis

City

Limburg

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Fundacao Pio XII

City

Barretos

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Universidade Federal De Minas Gerais - Hospital das Clínicas

City

Belo Horizonte

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

City

Florianopolis

ZIP/Postal Code

88034-000

Country

Brazil

Facility Name

Universidade Federal do Ceara - Hospital Universitario Walter Cantidio

City

Fortaleza

ZIP/Postal Code

60430-380

Country

Brazil

Facility Name

Fundacao Doutor Amaral Carvalho

City

Jau

ZIP/Postal Code

17210-080

Country

Brazil

Facility Name

Hospital das Clinicas de Porto Alegre

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

City

Sao Jose do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Real e Benemérita Associação Portuguesa de Beneficência

City

Sao Paulo

ZIP/Postal Code

01321-001

Country

Brazil

Facility Name

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

City

São Paulo

ZIP/Postal Code

01308-901

Country

Brazil

Facility Name

Fundação Antônio Prudente - A.C. Camargo Cancer Center

City

São Paulo

ZIP/Postal Code

01508-010

Country

Brazil

Facility Name

UMHAT 'Sveti Georgi'-Plovdiv

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Specialized Hospital for Active Treatment of Haematologic Diseases

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Hôpital d'Instruction des Armées Percy

City

Clamart

ZIP/Postal Code

92190

Country

France

Facility Name

Institut Universitaire du Cancer Toulouse - Oncopole

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

Hadassah Medical Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

57261

Country

Israel

Facility Name

Sourasky (Ichilov) Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Ematologia Fondazione Univ. Policlinico Gemelli Università Cattolica del Sacro Cuore

City

Roma

ZIP/Postal Code

168

Country

Italy

Facility Name

Akita University Hospital

City

Akita

ZIP/Postal Code

010-8543

Country

Japan

Facility Name

Chiba University Hospital

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Tokai University Hospital

City

Isehara

ZIP/Postal Code

259-1193

Country

Japan

Facility Name

Japanese Red Cross Society Nagano Hospital

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

Okayama University Hospital

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Hospital Ampang

City

Ampang Jaya

ZIP/Postal Code

68000

Country

Malaysia

Facility Name

Penang General Hospital

City

Georgetown

ZIP/Postal Code

10190

Country

Malaysia

Facility Name

University Malaya Medical Centre

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Sunway Medical Centre

City

Petaling Jaya, Selangor

ZIP/Postal Code

47500

Country

Malaysia

Facility Name

Leiden University Medical Center

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Hosp. Univ. Vall D Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hosp. de la Santa Creu i Sant Pau

City

Barcelona

ZIP/Postal Code

8041

Country

Spain

Facility Name

Hosp. Gral. Univ. Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hosp. Univ. 12 De Octubre

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hosp. Clinico Univ. de Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hosp. Univ. Marques De Valdecilla

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hosp. Virgen Del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Skanes universitetssjukhus

City

Malmö

ZIP/Postal Code

20502

Country

Sweden

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Kings College Hospital NHS Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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)

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