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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/NCT03333317
Registration number
NCT03333317
Ethics application status
Date submitted
16/10/2017
Date registered
6/11/2017
Date last updated
23/12/2019
Titles & IDs
Public title
A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
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Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
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Secondary ID [1]
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2017-001862-56
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Secondary ID [2]
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CR108367
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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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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 (Low-Dose Lumicitabine) - Participants will receive a single 40 milligram per kilogram (mg/kg) loading dose (LD) (Dose 1) followed by nine 20 mg/kg maintenance doses (MDs) (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.
Experimental: Regimen B (High-Dose Lumicitabine) - Participants will receive a single 60 mg/kg LD (Dose 1) followed by nine 40 mg/kg MDs (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.
Placebo Comparator: Regimen C (Placebo) - Participants will receive either a single 40 mg/kg placebo LD (Dose 1) followed by nine 20 mg/kg maintenance dose (MDs) (Doses 2 to 10) of placebo twice daily or single 60 mg/kg placebo LD (Dose 1) followed by nine 40 mg/kg placebo MDs (Doses 2 to 10), twice daily up to Day 5/6.
Treatment: Drugs: Lumicitabine
Participants will receive oral administration of lumicitabine.
Treatment: Drugs: Placebo
Participants will receive 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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Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
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Assessment method [1]
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AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
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Timepoint [1]
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Day 1 to 7: Predose, 0.25 and 2 hours postdose
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Secondary outcome [1]
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Number of Participants With Emergent Adverse Event
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Assessment method [1]
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An adverse event (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. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.
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Timepoint [1]
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Up to 28 days
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Secondary outcome [2]
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Number of Participants With Clinically Significant Physical Examinations Abnormalities
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Assessment method [2]
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The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported.
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Timepoint [2]
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Up to 28 days
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Secondary outcome [3]
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Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
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Assessment method [3]
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The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.
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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 Electrocardiogram (ECG) Abnormalities
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Assessment method [4]
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The number of participants with ECG (QT, and QTc intervals) abnormalities reported.
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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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Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
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Assessment method [5]
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Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.
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Timepoint [5]
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Up to 28 days
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Secondary outcome [6]
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Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
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Assessment method [6]
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Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).
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Timepoint [6]
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Day 1 and Day 5
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Secondary outcome [7]
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Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
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Assessment method [7]
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AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).
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Timepoint [7]
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Day 1 and Day 5
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Secondary outcome [8]
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Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
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Assessment method [8]
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C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine).
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Timepoint [8]
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Day 1 and Day 5
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Secondary outcome [9]
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Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)
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Assessment method [9]
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C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.
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Timepoint [9]
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12 hours postdose
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Secondary outcome [10]
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Length of Hospital Stay
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Assessment method [10]
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Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.
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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 Admitted to the Intensive Care Unit (ICU)
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Assessment method [11]
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Number of participants who were admitted to the ICU was 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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Duration of ICU Stay
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Assessment method [12]
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In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.
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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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Number of Participants Who Required Supplemental Oxygen
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Assessment method [13]
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The number of participants who required supplemental oxygen above pre-RSV infection status 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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Number of Participants Who Required Non-invasive Mechanical Ventilation Support
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Assessment method [14]
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The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.
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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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Number of Participants Who Required Invasive Mechanical Ventilation Support
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Assessment method [15]
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The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.
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Timepoint [15]
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Up to 28 days
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Secondary outcome [16]
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Duration of Supplemental Oxygen
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Assessment method [16]
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Duration of supplemental oxygen above pre-RSV infection status was assessed.
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Timepoint [16]
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Up to 28 days
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Secondary outcome [17]
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Duration of Non-invasive Mechanical Ventilation Support
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Assessment method [17]
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Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
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Timepoint [17]
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Up to 28 days
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Secondary outcome [18]
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Duration of Invasive Mechanical Ventilation Support
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Assessment method [18]
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Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.
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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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Time to no Longer Requiring Supplemental Oxygen
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Assessment method [19]
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Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.
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Timepoint [19]
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Up to 28 days
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Secondary outcome [20]
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Time to Clinical Stability
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Assessment method [20]
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Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the 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 [20]
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Up to 28 days
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Secondary outcome [21]
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Time From Initiation of Study Treatment 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 Onset of Respiratory Symptoms
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Assessment method [21]
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Time from initiation of study treatment 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 [21]
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Up to 28 days
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Secondary outcome [22]
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Time for Respiratory Rate to Return to Pre-RSV Infection Status
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Assessment method [22]
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Time for the respiratory rate to return to pre-RSV infection status was measured.
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Timepoint [22]
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Up to 28 days
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Secondary outcome [23]
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Time for SpO2 to Return to Pre-RSV Infection Status
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Assessment method [23]
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Time for SpO2 to return to pre-RSV infection status was measured.
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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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Time for Body Temperature to Return To Pre-RSV Infection Status
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Assessment method [24]
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Time for body temperature to return to pre-RSV infection status was measured.
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Timepoint [24]
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Up to 28 days
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Secondary outcome [25]
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Number of Participants With Acute Otitis Media
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Assessment method [25]
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Number of participants with acute otitis media was reported.
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Timepoint [25]
0
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Up to 28 days
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Secondary outcome [26]
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Duration of Signs and Symptoms of RSV Infection
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Assessment method [26]
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Duration of signs and symptoms of RSV infection was assessed.
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Timepoint [26]
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Up to 28 days
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Secondary outcome [27]
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Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
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Assessment method [27]
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The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).
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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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RSV Viral Load Over Time
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Assessment method [28]
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RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
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Timepoint [28]
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On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28
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Secondary outcome [29]
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Peak Viral Load
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Assessment method [29]
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Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
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Timepoint [29]
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Up to 28 days
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Secondary outcome [30]
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Time To Peak Viral Load
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Assessment method [30]
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Time to peak viral load was reported.
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Timepoint [30]
0
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Up to 28 days
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Secondary outcome [31]
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Percentage of Participants With Decline of Viral Load
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Assessment method [31]
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Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.
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Timepoint [31]
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Up to 28 days
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Secondary outcome [32]
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Time to RSV Ribonucleic Acid (RNA) Being Undetectable
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Assessment method [32]
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Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.
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Timepoint [32]
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Up to 28 days
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Secondary outcome [33]
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Percentage of Participants With Undetectable RSV Viral Load
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Assessment method [33]
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Percentage of participants with the undetectable viral load was reported.
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Timepoint [33]
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Up to 28 days
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Secondary outcome [34]
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AUC of RSV RNA Viral Load From Baseline up to Day 10
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Assessment method [34]
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AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
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Timepoint [34]
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Baseline up to Day 10
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Secondary outcome [35]
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AUC of RSV RNA Viral Load From Baseline up to Day 14
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Assessment method [35]
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AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
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Timepoint [35]
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Baseline up to Day 14
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Secondary outcome [36]
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AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug
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Assessment method [36]
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AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
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Timepoint [36]
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Baseline Until 1 Day after the last dose of study drug (up to 10 days)
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Secondary outcome [37]
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Number of Participants With Emergent 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 [37]
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Number of participants with emergent 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 [37]
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Baseline up to 28 days
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Secondary outcome [38]
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Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)
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Assessment method [38]
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Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).
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Timepoint [38]
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Up to Day 6
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Eligibility
Key inclusion criteria
- Participants hospitalized (or in emergency room [ER]) at the time of randomization and
unlikely to be discharged for the first 24 hours after randomization
- Participants diagnosed with respiratory syncytial virus (RSV) infection using a
polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without
co-infection with another respiratory pathogen (respiratory virus or bacteria)
- Participants who have an acute respiratory illness with signs and symptoms consistent
with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore
throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or
equal to <=5 days from the anticipated time of randomization. Onset of symptoms is
defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of
respiratory or systemic symptoms of RSV infection
- With the exception of the symptoms related to the RSV infection or defined comorbid
condition for severe RSV disease (prematurity at birth [participant's gestational age
was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary
dysplasia, congenital heart disease, other congenital diseases, Down syndrome,
neuromuscular impairment, or cystic fibrosis), participant must be medically stable on
the basis of physical examination, medical history, vital signs/peripheral capillary
oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there
are abnormalities, they must be consistent with the underlying condition 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. Participants with
comorbidities will be allowed to be enrolled once the Independent Data Monitoring
Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest
dose that will be used in this study and once the IDMC has recommended opening
recruitment to this group. Sites will be notified when the restriction is lifted
- The participant's estimated glomerular filtration rate (eGFR) is not below the lower
limit of normal for the participant's age
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Minimum age
28
Days
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Maximum age
36
Months
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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 have a known or suspected immunodeficiency (except immunoglobulin A
[IgA] deficiency), such as a known human immunodeficiency virus infection
- Participants being treated with extracorporeal membrane oxygenation
- Participant receiving chronic oxygen therapy at home prior to admission
- Participants who have a poorly functioning gastrointestinal tract (that is, unable to
absorb drugs or nutrition via enteral route)
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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
24/11/2017
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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
23/03/2018
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Sample size
Target
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
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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
Missouri
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New York
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Country [4]
0
0
United States of America
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State/province [4]
0
0
West Virginia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Wisconsin
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Bruxelles
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Country [7]
0
0
Canada
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State/province [7]
0
0
Ontario
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Country [8]
0
0
Hungary
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State/province [8]
0
0
Budapest
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Country [9]
0
0
Hungary
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State/province [9]
0
0
Miskolc
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Country [10]
0
0
Hungary
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State/province [10]
0
0
Nyíregyháza
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Country [11]
0
0
Japan
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State/province [11]
0
0
Fukuoka-shi
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Country [12]
0
0
Japan
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State/province [12]
0
0
Fukuoka
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Country [13]
0
0
Japan
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State/province [13]
0
0
Fukuyama
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Country [14]
0
0
Japan
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State/province [14]
0
0
Hatsukaichi
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Country [15]
0
0
Japan
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State/province [15]
0
0
Hirosaki
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Country [16]
0
0
Japan
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State/province [16]
0
0
Kanazawa
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Country [17]
0
0
Japan
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State/province [17]
0
0
Kitakyushu
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Country [18]
0
0
Japan
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State/province [18]
0
0
Niigata
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Country [19]
0
0
Japan
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State/province [19]
0
0
Oita
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Country [20]
0
0
Japan
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State/province [20]
0
0
Osaka
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Country [21]
0
0
Japan
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State/province [21]
0
0
Ota
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Country [22]
0
0
Japan
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State/province [22]
0
0
Saitama
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Country [23]
0
0
Japan
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State/province [23]
0
0
Shibukawa
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Country [24]
0
0
Japan
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State/province [24]
0
0
Zentsuji
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Country [25]
0
0
Poland
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State/province [25]
0
0
Malopolska
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Country [26]
0
0
Poland
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State/province [26]
0
0
Poznan
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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 determine in hospitalized infants and children who are
infected with respiratory syncytial virus (RSV) 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03333317
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03333317
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