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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/NCT02935673
Registration number
NCT02935673
Ethics application status
Date submitted
14/10/2016
Date registered
17/10/2016
Date last updated
24/12/2019
Titles & IDs
Public title
Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus
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Scientific title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus
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Secondary ID [1]
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0
2016-001653-40
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Secondary ID [2]
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CR108217
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - lumicitabine
Treatment: Drugs - Placebo
Experimental: Regimen A (Placebo) - Participants of part 1 and part 2 will receive a single loading dose (LD) (Dose 1) followed by 9 maintenance doses (MDs) (Doses 2 to 10) of matching placebo, administered twice daily.
Experimental: Regimen B (low-dose lumicitabine) - Participants of part 1 and part 2 will receive a single 750 mg LD (Dose 1) followed by nine 250 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.
Experimental: Regimen C (High-dose lumicitabine) - Participants of part 2 will receive a single 1000 mg LD (Dose 1) followed by nine 500 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.
Treatment: Drugs: lumicitabine
Oral administration of lumicitabine as tablet.
Treatment: Drugs: Placebo
Oral administration of matching placebo.
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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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Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1
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Assessment method [1]
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Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [1]
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Day 1
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Primary outcome [2]
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Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5
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Assessment method [2]
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Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [2]
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Day 5
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Primary outcome [3]
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Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1
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Assessment method [3]
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AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [3]
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Day 1
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Primary outcome [4]
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Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5
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Assessment method [4]
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AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [4]
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Day 5
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Primary outcome [5]
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Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1
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Assessment method [5]
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Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [5]
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Day 1
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Primary outcome [6]
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Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5
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Assessment method [6]
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Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
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Timepoint [6]
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Day 5
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Primary outcome [7]
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Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7])
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Assessment method [7]
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RSV RNA viral load in log10 copies/milliliter/day (log10 copies/mL/day) was measured in mid-turbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Due to early termination of study, the analysis was not conducted as planned. Instead, using the same specification as for the primary analysis, a comparison was made on the AUC(1-7) days of pooled active treatment groups versus pooled placebo. The comparison was done as planned using a mixed model for repeated measures, using all available viral load data of baseline up to and including Day 7. The model computes the AUC at group level based on all available data, taking missing data into account under the missing at random assumption. The table reports the planned difference versus (pooled) placebo. No adjustment for multiplicity was applied.
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Timepoint [7]
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Day 1 (Baseline) to 7
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Secondary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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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 does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
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Timepoint [1]
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0
Up to 28 Days
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Secondary outcome [2]
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Number of Participants With Vital Sign Abnormalities
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Assessment method [2]
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Number of participants with vital sign (systolic and diastolic blood pressure [BP], pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported. For systolic BP: abnormally low refers to less than or equal to (<=) 90 millimeter of mercury (mmHg); for diastolic BP: abnormally low refers to <= 50 mmHg; for pulse rate abnormally low refers to less than (<) 45 beats per minutes (bpm) and abnormally high refers to greater than or equal to (>=) 120 bpm; for temperature in degree Celsius abnormally high refers to greater than (>) 37.8 (tympanic), >38.0 (forehead), >38.0 (oral), >37.2 (rectal), >38.0 (axillary); for oxygen saturation in percentage (%) abnormally low refers to < 95. Grade 1 = mild; grade 2 = moderate; grade 3 = severe.
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Timepoint [2]
0
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Up to 28 Days
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Secondary outcome [3]
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Number of Participants With QT Interval Abnormalities
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Assessment method [3]
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Number of participants with QT interval abnormalities (prolonged) were reported.
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Timepoint [3]
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Up to 28 Days
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Secondary outcome [4]
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Number of Participants With Clinical Laboratory Abnormalities
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Assessment method [4]
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Number of participants with clinical laboratory (serum chemistry and hematology) abnormalities were reported. Abbreviations; Erythrocyte MCHC = Erythrocyte Mean Corpuscular Hemoglobin Concentration; Erythrocyte MCH = Erythrocyte Mean Corpuscular Hemoglobin; Ery. = Erythrocyte
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Timepoint [4]
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Up to 28 Days
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Secondary outcome [5]
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Time of Hospital Stay From Study Treatment Initiation to Discharge
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Assessment method [5]
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It is the time from treatment initiation to hospital discharge in hours.
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Timepoint [5]
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From study treatment initiation to discharge (Up to 28 Days)
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Secondary outcome [6]
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Time of Hospital Stay From Admission to Discharge
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Assessment method [6]
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It is the time from hospital admission to hospital discharge in hours.
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Timepoint [6]
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From admission to discharge (Up to 28 Days)
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Secondary outcome [7]
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Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge
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Assessment method [7]
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It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator.
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Timepoint [7]
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From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged
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Secondary outcome [8]
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Time of Hospital Stay From Admission to Readiness for Discharge
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Assessment method [8]
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It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator.
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Timepoint [8]
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Up to 28 Days
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Secondary outcome [9]
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Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment
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Assessment method [9]
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Number of participants who required to be admitted to the ICU since initiation of treatment were reported.
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Timepoint [9]
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Up to 28 Days
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Secondary outcome [10]
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Duration of Intensive Care Unit Stay
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Assessment method [10]
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In the event that a participant required ICU since initiation of treatment, the duration for how long the participant remained in the ICU was measured.
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Timepoint [10]
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Up to 28 Days
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Secondary outcome [11]
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Number of Participants Who Required Supplemental Oxygen
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Assessment method [11]
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Number of participants who required supplemental oxygen were reported.
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Timepoint [11]
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Up to 28 Days
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Secondary outcome [12]
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Time to End of Oxygen Supplementation
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Assessment method [12]
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It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours.
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Timepoint [12]
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Up to 28 Days
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Secondary outcome [13]
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Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms
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Assessment method [13]
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Time (number of hours) until SpO2 >= 93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
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Timepoint [13]
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Up to 28 Days
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Secondary outcome [14]
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Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate
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Assessment method [14]
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It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
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Timepoint [14]
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Up to 28 Days
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Secondary outcome [15]
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Time to Return to Pre-RSV Disease Level for Oxygen Saturation
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Assessment method [15]
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It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
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Timepoint [15]
0
0
Up to 28 Days
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Secondary outcome [16]
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Time to Return to Pre-RSV Disease Level for Body Temperature
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Assessment method [16]
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0
It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
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Timepoint [16]
0
0
Up to 28 Days
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Secondary outcome [17]
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Number of Participants Who Required Noninvasive Mechanical Ventilation Support
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Assessment method [17]
0
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Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported.
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Timepoint [17]
0
0
Up to 28 Days
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Secondary outcome [18]
0
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Time to End of Noninvasive Mechanical Ventilation Support
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Assessment method [18]
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It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours.
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Timepoint [18]
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Up to 28 Days
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Secondary outcome [19]
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Number of Participants Who Required Invasive Mechanical Ventilation Support
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Assessment method [19]
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Number of participants who required invasive mechanical ventilation support were reported.
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Timepoint [19]
0
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Up to 28 Days
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Secondary outcome [20]
0
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Time to End of Invasive Mechanical Ventilation Support
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Assessment method [20]
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It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours.
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Timepoint [20]
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Up to 28 Days
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Secondary outcome [21]
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Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score
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Assessment method [21]
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It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is the total points on the KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding the scores for all 6 activities which ranges from 0 high (participant independent) to 6 low (participant very dependent). If one or more component was missing, then the KATZ ADL score was not calculated. The return to pre-RSV functional status occurs at the timepoint where for the first time the KATZ ADL score is equal or higher than the pre-RSV KATZ ADL score and after which no scores lower than the pre-RSV KATZ ADL score occur anymore.
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Timepoint [21]
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Up to 28 Days
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Secondary outcome [22]
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Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
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Assessment method [22]
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Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported.
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Timepoint [22]
0
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Up to 28 Days
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Secondary outcome [23]
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Time to Clinical Stability
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Assessment method [23]
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Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate.
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Timepoint [23]
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Up to 28 Days
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Secondary outcome [24]
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Number of Participants in Each Ordinal Scale Category
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Assessment method [24]
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Number of participants in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities.
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Timepoint [24]
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Day 5/6 (Day of last study treatment)
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Secondary outcome [25]
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Number of Participants With All-Cause Mortality
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Assessment method [25]
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All-cause mortality included all deaths of participants due to any cause.
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Timepoint [25]
0
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Up to 28 Days
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Secondary outcome [26]
0
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RSV RNA Viral Load Over Time
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Assessment method [26]
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Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated participants) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory.
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Timepoint [26]
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Days 2, 3, 4, 5, 6, 7, 10, 14, and 28
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Secondary outcome [27]
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Peak Viral Load
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Assessment method [27]
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Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR.
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Timepoint [27]
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Up to 28 Days
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Secondary outcome [28]
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Time to Peak Viral Load
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Assessment method [28]
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Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.
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Timepoint [28]
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Up to 28 Days
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Secondary outcome [29]
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Rate of Decline of Viral Load
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Assessment method [29]
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Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (-) log viral load at baseline divided by (/) date/time of 24-hour viral load sample - date/time of baseline viral load.
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Timepoint [29]
0
0
Up to 28 Days
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Secondary outcome [30]
0
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Time to RSV RNA Viral Load Being Undetectable
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Assessment method [30]
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It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR.
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Timepoint [30]
0
0
Up to 28 Days
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Secondary outcome [31]
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Number of Participants With Undetectable Viral Load
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Assessment method [31]
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0
Number of participants with undetectable viral load up to 28 days were reported.
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Timepoint [31]
0
0
Up to 28 Days
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Secondary outcome [32]
0
0
RSV RNA Viral Load AUC up to Day 14
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Assessment method [32]
0
0
RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.
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Timepoint [32]
0
0
Up to Day 14
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Secondary outcome [33]
0
0
RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration
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Assessment method [33]
0
0
RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.
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Timepoint [33]
0
0
Up to 1 Day after the last dose of study drug
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Secondary outcome [34]
0
0
Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences
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Assessment method [34]
0
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Number of participants with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported.
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Timepoint [34]
0
0
Baseline up to 28 Days
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Eligibility
Key inclusion criteria
- Hospitalized (or in emergency room prior to hospitalization) at the time of
randomization and unlikely to be discharged for the first 24 hours after randomization
- Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain
reaction (PCR)-based assay with or without co infection with another respiratory
pathogen (eg, influenza, human metapneumovirus, or bacteria)
- With the exception of the RSV disease, medically stable on the basis of medical
history, physical examination, vital signs, and 12-lead electrocardiogram (ECG)
performed at screening. If there are abnormalities, they must be consistent with the
underlying illness in the study population and/or the RSV infection. This
determination must be recorded in the participant's source documents and initialed by
the investigator
- A woman must have a negative urine beta human chorionic gonadotropin at screening
- A woman must agree not to donate eggs (ova, oocytes) during the study and for at least
44 days after receiving the last dose of study drug
- Contraceptive use by women should be consistent with local regulations regarding the
use of contraceptive methods for participants participating in clinical studies A
woman must be of non-childbearing potential defined as either: a) Postmenopausal: a
postmenopausal state is defined as more than (>) 45 years and no menses for 12
consecutive months without an alternative medical cause, OR Permanently sterile:
permanent sterilization methods include hysterectomy, bilateral salpingectomy,
bilateral tubal occlusion/ligation procedures (without reversal operation), and
bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active,
also included: practicing a highly effective method of contraception (failure rate of
less than (<) 1percent (%) per year when used consistently and correctly)
- Participants must have a body weight of at least 50.0 kilogram, at screening
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Minimum age
18
Years
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Maximum age
No limit
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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
- Participants who are not expected to survive for more than 48 hours
- Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to
randomization
- Participants who are considered by the investigator to be immuno-compromised within
the past 12 months, whether due to underlying medical condition (example, malignancy
or genetic disorder) or medical therapy (example, medications other than
corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or
asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)
- Participants with a known history of human immunodeficiency virus (HIV) or chronic
viral hepatitis
- Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with
an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease
Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute
(mL/min) per 1.73 meter square (m^2)
- Participants with 1 or more of the following laboratory abnormalities at screening as
defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity
Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per
millimeter cube (/mm^³), White blood cell count <1,000/mm^³, Absolute neutrophil count
<1,000/mm^³
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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
25/10/2016
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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
17/07/2018
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Sample size
Target
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Accrual to date
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Final
49
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
- Cairns
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Recruitment hospital [2]
0
0
- Geelong
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Recruitment hospital [3]
0
0
- Melbourne
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Recruitment hospital [4]
0
0
- South Brisbane
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Recruitment hospital [5]
0
0
- Sydney
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Recruitment postcode(s) [1]
0
0
- Cairns
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Recruitment postcode(s) [2]
0
0
- Geelong
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Recruitment postcode(s) [3]
0
0
- Melbourne
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Recruitment postcode(s) [4]
0
0
- South Brisbane
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Recruitment postcode(s) [5]
0
0
- Sydney
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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
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Georgia
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Missouri
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Montana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
New York
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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
Barrio Parque Velez Sarfield
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Buenos Aires
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Ciudad de Buenos Aires
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Ciudad De La Plata
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Cordoba
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0
Argentina
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State/province [14]
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0
Córdoba
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Argentina
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La Plata
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Argentina
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Rosario
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Belgium
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Brugge
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Belgium
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Lier
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Brazil
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Belo Horizonte
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Sao Paulo
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Bulgaria
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Kozloduy
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Bulgaria
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Petrich
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Veliko Tarnovo
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Canada
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Ontario
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France
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Colombes
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France
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Dijon
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Country [32]
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France
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State/province [32]
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La Tronche
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Country [33]
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France
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Limoges
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Country [34]
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France
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Lyon
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France
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Morlaix
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France
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Nantes
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France
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Paris
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France
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Poitiers
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France
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Suresnes
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France
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Tours
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Germany
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Marburg
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Germany
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Witten
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Japan
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Fukuoka
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Japan
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Fukushima
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Japan
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Gifu
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Japan
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Gunma
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0
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Japan
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Hamamatue
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Japan
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Isahaya
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0
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Japan
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Izumo
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Japan
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Kitakyusyu
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Japan
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Kobe-city,
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Japan
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Nagasaki
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0
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Japan
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Nagoya
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Japan
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Osaka
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Japan
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Ota
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Japan
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Sendai
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Japan
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Seto
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Japan
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Shiogama
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Country [59]
0
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Japan
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Tanabe
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Country [60]
0
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Japan
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State/province [60]
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Tokai-mura
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Country [61]
0
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Japan
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Tokyo
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Country [62]
0
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Japan
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Tsu
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Country [63]
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Japan
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State/province [63]
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Uruma
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Country [64]
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Korea, Republic of
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Bucheon
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Country [65]
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Korea, Republic of
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Daegu
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Country [66]
0
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Korea, Republic of
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State/province [66]
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Gwangju
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Country [67]
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Korea, Republic of
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State/province [67]
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Incheon
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Country [68]
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Korea, Republic of
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State/province [68]
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Seongnam
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Country [69]
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Korea, Republic of
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State/province [69]
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Seoul
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Country [70]
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Malaysia
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Johor Bharu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuala
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Malaysia
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Kuching
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Malaysia
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Melaka
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Country [75]
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Malaysia
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Miri
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Malaysia
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Taiping
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Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Country [81]
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Netherlands
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Leiden
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Country [82]
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Netherlands
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Utrecht
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Country [83]
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Poland
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Bialystok
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Country [84]
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Poland
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Checiny
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Country [85]
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Poland
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Mrozy
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Country [86]
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Poland
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State/province [86]
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Proszowice
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Spain
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Elche
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Country [88]
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Spain
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Granada
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Spain
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Vigo
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Country [92]
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Sweden
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Göteborg
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Country [93]
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Sweden
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Malmö
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Country [94]
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Sweden
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Umeå
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Country [95]
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Country [97]
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Taiwan
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State/province [97]
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New Taipei
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Country [98]
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Taiwan
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Tainan
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Country [99]
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Taiwan
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Taipei
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Country [100]
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United Kingdom
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London
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Country [101]
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK
model derived from healthy volunteers in hospitalized adults who are infected with
respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with
respiratory syncytial virus (RSV) infection the dose response relationship of multiple
regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative
real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02935673
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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0
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Phone
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02935673
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