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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04056611
Registration number
NCT04056611
Ethics application status
Date submitted
13/08/2019
Date registered
14/08/2019
Date last updated
14/04/2023
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)
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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
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Secondary ID [1]
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53718678RSV2005
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Secondary ID [2]
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CR108662
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Universal Trial Number (UTN)
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Trial acronym
FREESIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Developed Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Infection (LRTI)
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Assessment method [1]
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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).
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Timepoint [1]
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Up to Day 28
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Secondary outcome [1]
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Percentage of Participants Who Developed RSV-associated Lower Respiratory Tract Complication (LRTC)
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Assessment method [1]
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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).
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Timepoint [1]
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Up to Day 28
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Secondary outcome [2]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Day 49
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Secondary outcome [3]
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Percentage of Participants With Treatment-emergent Abnormal (>=Grade 3) Clinical Laboratory Findings
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Assessment method [3]
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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).
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Timepoint [3]
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Up to Day 49
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Secondary outcome [4]
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Percentage of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Findings
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Assessment method [4]
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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.)
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Timepoint [4]
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Up to Day 49
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Secondary outcome [5]
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Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
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Assessment method [5]
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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).
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Timepoint [5]
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Up to Day 49
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
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Up to Day 49
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Secondary outcome [7]
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Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) and/or Death (All-cause Mortality)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to Day 49
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Secondary outcome [8]
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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
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Assessment method [8]
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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.
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Timepoint [8]
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Up to Day 49
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Secondary outcome [9]
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Percentage of Participants Who Progressed to Death (All-cause Mortality)
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Assessment method [9]
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Percentage of participants who progressed to death (all-cause mortality) was assessed.
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Timepoint [9]
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Up to Day 49
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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Up to Day 49
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Secondary outcome [11]
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Percentage of Participants Who Progressed to Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive)
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Assessment method [11]
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Percentage of participants who progressed to respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) was assessed.
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Timepoint [11]
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Up to Day 49
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Secondary outcome [12]
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Number of Supplemental Oxygen Free Days
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Assessment method [12]
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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.
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Timepoint [12]
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Through Day 28
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Secondary outcome [13]
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Percentage of Participants With Treatment-emergent Oxygen Supplementation
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Assessment method [13]
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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.
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Timepoint [13]
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0
Up to Day 49
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Secondary outcome [14]
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Respiratory Rate Over Time
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Assessment method [14]
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Respiratory rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
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Timepoint [14]
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Baseline (Day 1), Days 15, 28, and 35
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Secondary outcome [15]
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Heart Rate Over Time
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Assessment method [15]
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Heart rate over time was reported by investigator. In this outcome measure, only those timepoints in which individual participant had data were reported.
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Timepoint [15]
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Baseline (Day 1), Days 15, 28, and 35
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Secondary outcome [16]
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Peripheral Capillary Oxygen Saturation (SpO2) Over Time
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline (Day 1), Days 15, 28, and 35
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Secondary outcome [17]
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Body Temperature Over Time
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Assessment method [17]
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Body temperature (in Degrees Celsius) over time was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
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Timepoint [17]
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Baseline (Day 1), Days 15, 28, and 35
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Secondary outcome [18]
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Percentage of Participants Hospitalized (of Participants Who Were Not Hospitalized at Baseline)
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Assessment method [18]
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Percentage of participants who were not hospitalized at baseline and required hospitalization during the study was assessed.
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Timepoint [18]
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Up to Day 49
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Secondary outcome [19]
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Percentage of Participants Who Were Re-hospitalized
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Assessment method [19]
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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.
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Timepoint [19]
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Up to Day 49
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Secondary outcome [20]
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Duration of Hospital Stay
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Assessment method [20]
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Duration (in days) of hospital stay was assessed.
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Timepoint [20]
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Up to Day 49
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Secondary outcome [21]
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Duration of Intensive Care Unit (ICU) Stay
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Assessment method [21]
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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.
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Timepoint [21]
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Up to Day 49
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Secondary outcome [22]
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Number of Participants With Grade 3 and Grade 4 Treatment-emergent Adverse Events (TEAEs) in the Infections and Infestations System Organ Class
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Assessment method [22]
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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.
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Timepoint [22]
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Up to Day 49
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Secondary outcome [23]
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Number of Participants With Respiratory Related AEs
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Assessment method [23]
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Number of participants with respiratory related AEs (respiratory infections) was assessed.
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Timepoint [23]
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Up to Day 49
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Secondary outcome [24]
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Number of Participants With Thoracic-related AEs
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Assessment method [24]
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Number of participants with thoracic-related AEs was assessed.
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Timepoint [24]
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Up to Day 49
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Secondary outcome [25]
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Number of Participants With Antibiotic Use Among Those Who Developed RSV LRTI or RSV-Associated LRTC Per the EAC's Assessment
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Assessment method [25]
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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.
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Timepoint [25]
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Up to Day 49
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Secondary outcome [26]
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Plasma Concentration of JNJ-53718678
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Assessment method [26]
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Plasma Concentration of JNJ-53718678 was reported. In this outcome measure, only those timepoints in which individual participant had data were reported.
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Timepoint [26]
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Days 1, 3, 8, 15 and 22
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Secondary outcome [27]
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RSV Viral Load Over Time
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Assessment method [27]
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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.
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Timepoint [27]
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Baseline (Day 1), Days 15, 28, and 35
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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
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Minimum age
13
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/02/2022
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Sample size
Target
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Accrual to date
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Final
3
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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0
Royal Melbourne Hospital - Melbourne
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Recruitment hospital [3]
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0
Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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3050 - Melbourne
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Michigan
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Minnesota
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Ohio
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Pennsylvania
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Bahia Blanca
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Ciudad De La Plata
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Cordoba
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Country [11]
0
0
Argentina
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State/province [11]
0
0
San Miguel de Tucuman
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Brugge
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Country [13]
0
0
Belgium
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State/province [13]
0
0
Brussels
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Country [14]
0
0
Belgium
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State/province [14]
0
0
Gent
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Country [15]
0
0
Belgium
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State/province [15]
0
0
Leuven
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Liege
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Country [17]
0
0
Belgium
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State/province [17]
0
0
Limburg
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Country [18]
0
0
Brazil
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State/province [18]
0
0
Barretos
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Belo Horizonte
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Florianopolis
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Fortaleza
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Country [22]
0
0
Brazil
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State/province [22]
0
0
Jau
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Porto Alegre
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Country [24]
0
0
Brazil
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State/province [24]
0
0
Sao Jose do Rio Preto
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Country [25]
0
0
Brazil
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State/province [25]
0
0
Sao Paulo
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Country [26]
0
0
Brazil
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State/province [26]
0
0
São Paulo
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Country [27]
0
0
Bulgaria
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State/province [27]
0
0
Plovdiv
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Country [28]
0
0
Bulgaria
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State/province [28]
0
0
Sofia
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Country [29]
0
0
Bulgaria
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State/province [29]
0
0
Varna
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Country [30]
0
0
France
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State/province [30]
0
0
Clamart
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Country [31]
0
0
France
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State/province [31]
0
0
Toulouse
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Country [32]
0
0
Israel
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State/province [32]
0
0
Haifa
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Country [33]
0
0
Israel
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State/province [33]
0
0
Jerusalem
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Country [34]
0
0
Israel
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State/province [34]
0
0
Ramat Gan
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Country [35]
0
0
Israel
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State/province [35]
0
0
Tel Aviv
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Country [36]
0
0
Italy
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State/province [36]
0
0
Milano
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Country [37]
0
0
Italy
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State/province [37]
0
0
Roma
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Country [38]
0
0
Japan
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State/province [38]
0
0
Akita
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Country [39]
0
0
Japan
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State/province [39]
0
0
Chiba
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Country [40]
0
0
Japan
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State/province [40]
0
0
Isehara
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Country [41]
0
0
Japan
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State/province [41]
0
0
Nagano
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Country [42]
0
0
Japan
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State/province [42]
0
0
Okayama
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Country [43]
0
0
Korea, Republic of
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Seoul
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Malaysia
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Ampang Jaya
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Malaysia
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Georgetown
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Malaysia
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Kuala Lumpur
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Malaysia
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Petaling Jaya, Selangor
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Netherlands
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Leiden
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Sevilla
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Sweden
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Malmö
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Sciences Ireland UC
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04056611
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Public notes
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Contacts
Principal investigator
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Janssen Sciences Ireland UC Clinical Trial
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Address
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Janssen Sciences Ireland UC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04056611
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