Respiratory syncytial virus infection MedDRA version: 20.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Lumicitabine
Product Code: JNJ-64041575
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: Lumicitabine
CAS Number: 1445385-02-3
Current Sponsor code: JNJ-6
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female infants and children =28 days to =36 months of age, defined at the time of randomization. • Subjects hospitalized (or in ER) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization. • Subjects diagnosed with RSV infection using a PCR-based molecular diagnostic assay, with or without coinfection with another respiratory pathogen (respiratory virus or bacteria). • Subjects who have an acute respiratory illness with signs and symptoms consistent with a viral infection (eg, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset =5 days from the anticipated time of randomization. • With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [subject’s gestational age was =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects who are not expected to survive for more than 48 hours. • Subjects who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization. • Subjects who received (within 12 months prior to screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, who received radiation or chemotherapy, or who are currently taking immunosuppressive medication. • Subjects who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection. • Subjects who have a history of or concurrent illness (beyond a defined comorbid condition for severe RSV disease) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. • Subjects aged =28 days to 35 days with <8.0 g/dL (Grade 3) hemoglobin or a cardiac failure secondary to anemia (Grade 4) and subjects aged =36 days to 36 months with <7.0 g/dL (Grade 3) hemoglobin or cardiac failure secondary to anemia (Grade 4). • Subjects aged =28 days to 60 days with <899/mm3 absolute neutrophil count) and subjects aged =61 days to =36 months with <399/mm3 absolute neutrophil count. • Subjects aged =28 days to =36 months with <49,999/mm3 platelet count (Grade 3/4).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine in hospitalized infants and children who are infected with RSV the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using qRT-PCR.;Secondary Objective: To determine in hospitalized infants and children who are infected with RSV: • The safety and tolerability of lumicitabine. • The PK of JNJ-63549109 in whole blood. • The impact of lumicitabine on the clinical course of RSV infection. • The impact of lumicitabine on the duration and severity of signs and symptoms of RSV infection as assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) questionnaire completed by the clinician in the electronic clinical outcome assessment (eCOA) device. • The impact of lumicitabine on the time to undetectable nasal RSV viral load. • The impact of lumicitabine on the emergence of RSV strains with resistance-associated mutations. • The relationship between the PK of JNJ-63549109 and the PD (antiviral activity, clinical symptoms, and selected safety parameters) after single (LD) and repeated oral dosing (MD) of lumicitabine. • The acceptability and palatability of the lumicitabine formulation.;Primary end point(s): The primary endpoint in this study is RSV RNA log10 viral load (measured by qRT-PCR assay in the mid-turbinate nasal swab specimens) AUC immediately prior to first dose of study drug (baseline) over 7 days.;Timepoint(s) of evaluation of this end point: Samples for the determination of RSV viral load will be taken as close as possible and before the LD on Day 1 and once daily at approximately the same time each day prior to study drug administration between Day 2 and Day 6 (whether hospitalized or not), and at the Day 7, Day 10, Day 14, and Day 28 visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety/tolerability including adverse events (AEs), physical examinations, vital signs/peripheral capillary oxygen saturation (SpO2), electrocardiogram (ECG), and clinical laboratory results. • PK parameters of JNJ-63549109. • RSV clinical course endpoints: o Length of hospital stay from admission to discharge and to readiness for discharge and from study treatment initiation to discharge and to readiness for discharge, with readiness for discharge evaluated by the investigator. o Requirement for and duration of intensive care unit (ICU) stay. o Requirement for and duration of oxygen supplementation/noninvasive mechanical ventilation support and/or invasive mechanical ventilation support above pre-RSV infection status. o Time to no longer requiring supplemental oxygen above pre-RSV infection status. o Time to clinical stability defined as the time from initiation of study treatment until the time at which the following criteria are met: return to pre-RSV infection status (hereafter referred to as “normalization”) of blood oxygen level (ie, without additional requirement of supplemental oxygen compared with pre-RSV infection status), normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate. o Time from initiation of study treatment until SpO2 =93% on room air among subjects who were not on supplemental oxygen prior to the onset of respiratory symptoms. o Time to respiratory rate, SpO2, and body temperature return to pre-RSV infection status. o Incidence of acute otitis media (defined by the investigator). • The duration and severity of signs and symptoms of RSV infection as assessed by the PRESORS questionnaire completed by the clinician in the eCOA device. • RSV viral load as measured by qRT-PCR in the mid-turbinate nasal swab specimens, which will be used to determine the following: o RSV viral load over time. o Peak viral load, time to peak viral load, rate of decline of viral load, and time to RSV | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Panama, Poland, Portugal, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed