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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2017-001862-56
Secondary ID [2] 0 0
CR108367
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Timepoint [1] 0 0
Day 1 to 7: Predose, 0.25 and 2 hours postdose
Secondary outcome [1] 0 0
Number of Participants With Emergent Adverse Event
Timepoint [1] 0 0
Up to 28 days
Secondary outcome [2] 0 0
Number of Participants With Clinically Significant Physical Examinations Abnormalities
Timepoint [2] 0 0
Up to 28 days
Secondary outcome [3] 0 0
Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Timepoint [3] 0 0
Up to 28 days
Secondary outcome [4] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Timepoint [5] 0 0
Up to 28 days
Secondary outcome [6] 0 0
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Timepoint [6] 0 0
Day 1 and Day 5
Secondary outcome [7] 0 0
Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
Timepoint [7] 0 0
Day 1 and Day 5
Secondary outcome [8] 0 0
Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
Timepoint [8] 0 0
Day 1 and Day 5
Secondary outcome [9] 0 0
Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)
Timepoint [9] 0 0
12 hours postdose
Secondary outcome [10] 0 0
Length of Hospital Stay
Timepoint [10] 0 0
Up to 28 days
Secondary outcome [11] 0 0
Number of Participants Admitted to the Intensive Care Unit (ICU)
Timepoint [11] 0 0
Up to 28 days
Secondary outcome [12] 0 0
Duration of ICU Stay
Timepoint [12] 0 0
Up to 28 days
Secondary outcome [13] 0 0
Number of Participants Who Required Supplemental Oxygen
Timepoint [13] 0 0
Up to 28 days
Secondary outcome [14] 0 0
Number of Participants Who Required Non-invasive Mechanical Ventilation Support
Timepoint [14] 0 0
Up to 28 days
Secondary outcome [15] 0 0
Number of Participants Who Required Invasive Mechanical Ventilation Support
Timepoint [15] 0 0
Up to 28 days
Secondary outcome [16] 0 0
Duration of Supplemental Oxygen
Timepoint [16] 0 0
Up to 28 days
Secondary outcome [17] 0 0
Duration of Non-invasive Mechanical Ventilation Support
Timepoint [17] 0 0
Up to 28 days
Secondary outcome [18] 0 0
Duration of Invasive Mechanical Ventilation Support
Timepoint [18] 0 0
Up to 28 days
Secondary outcome [19] 0 0
Time to no Longer Requiring Supplemental Oxygen
Timepoint [19] 0 0
Up to 28 days
Secondary outcome [20] 0 0
Time to Clinical Stability
Timepoint [20] 0 0
Up to 28 days
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Up to 28 days
Secondary outcome [22] 0 0
Time for Respiratory Rate to Return to Pre-RSV Infection Status
Timepoint [22] 0 0
Up to 28 days
Secondary outcome [23] 0 0
Time for SpO2 to Return to Pre-RSV Infection Status
Timepoint [23] 0 0
Up to 28 days
Secondary outcome [24] 0 0
Time for Body Temperature to Return To Pre-RSV Infection Status
Timepoint [24] 0 0
Up to 28 days
Secondary outcome [25] 0 0
Number of Participants With Acute Otitis Media
Timepoint [25] 0 0
Up to 28 days
Secondary outcome [26] 0 0
Duration of Signs and Symptoms of RSV Infection
Timepoint [26] 0 0
Up to 28 days
Secondary outcome [27] 0 0
Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Timepoint [27] 0 0
Up to 28 days
Secondary outcome [28] 0 0
RSV Viral Load Over Time
Timepoint [28] 0 0
On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28
Secondary outcome [29] 0 0
Peak Viral Load
Timepoint [29] 0 0
Up to 28 days
Secondary outcome [30] 0 0
Time To Peak Viral Load
Timepoint [30] 0 0
Up to 28 days
Secondary outcome [31] 0 0
Percentage of Participants With Decline of Viral Load
Timepoint [31] 0 0
Up to 28 days
Secondary outcome [32] 0 0
Time to RSV Ribonucleic Acid (RNA) Being Undetectable
Timepoint [32] 0 0
Up to 28 days
Secondary outcome [33] 0 0
Percentage of Participants With Undetectable RSV Viral Load
Timepoint [33] 0 0
Up to 28 days
Secondary outcome [34] 0 0
AUC of RSV RNA Viral Load From Baseline up to Day 10
Timepoint [34] 0 0
Baseline up to Day 10
Secondary outcome [35] 0 0
AUC of RSV RNA Viral Load From Baseline up to Day 14
Timepoint [35] 0 0
Baseline up to Day 14
Secondary outcome [36] 0 0
AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug
Timepoint [36] 0 0
Baseline Until 1 Day after the last dose of study drug (up to 10 days)
Secondary outcome [37] 0 0
Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Timepoint [37] 0 0
Baseline up to 28 days
Secondary outcome [38] 0 0
Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)
Timepoint [38] 0 0
Up to Day 6

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
Minimum age
28 Days
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/03/2018
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
West Virginia
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
Hungary
State/province [9] 0 0
Miskolc
Country [10] 0 0
Hungary
State/province [10] 0 0
Nyíregyháza
Country [11] 0 0
Japan
State/province [11] 0 0
Fukuoka-shi
Country [12] 0 0
Japan
State/province [12] 0 0
Fukuoka
Country [13] 0 0
Japan
State/province [13] 0 0
Fukuyama
Country [14] 0 0
Japan
State/province [14] 0 0
Hatsukaichi
Country [15] 0 0
Japan
State/province [15] 0 0
Hirosaki
Country [16] 0 0
Japan
State/province [16] 0 0
Kanazawa
Country [17] 0 0
Japan
State/province [17] 0 0
Kitakyushu
Country [18] 0 0
Japan
State/province [18] 0 0
Niigata
Country [19] 0 0
Japan
State/province [19] 0 0
Oita
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Ota
Country [22] 0 0
Japan
State/province [22] 0 0
Saitama
Country [23] 0 0
Japan
State/province [23] 0 0
Shibukawa
Country [24] 0 0
Japan
State/province [24] 0 0
Zentsuji
Country [25] 0 0
Poland
State/province [25] 0 0
Malopolska
Country [26] 0 0
Poland
State/province [26] 0 0
Poznan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT03333317
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03333317