Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02593851
Registration number
NCT02593851
Ethics application status
Date submitted
21/08/2015
Date registered
1/11/2015
Date last updated
6/12/2019
Titles & IDs
Public title
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
Query!
Scientific title
A Phase 1b, Randomized, Partially Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With RSV Infection
Query!
Secondary ID [1]
0
0
2015-002003-28
Query!
Secondary ID [2]
0
0
CR107945
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections
0
0
Query!
Virus Diseases
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Sexually transmitted infections
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-53718678
Treatment: Drugs - Placebo
Experimental: Part 1: Cohort 1a - Participants (greater than or equal to \[\>=\] 6 months and less than or equal to \[\<=\] 24 months of age) will receive JNJ-53718678, 2 milligram per kilogram body weight (mg/kg) oral solution once daily on Day 1 to Day 7. Dose and/or dosing regimen may be adapted in subsequent cohorts based on the review of the safety/tolerability and full pharmacokinetic data from Cohort 1a.
Experimental: Part 1: Cohort 1b - Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 6 mg/kg JNJ-53718678 oral solution or placebo \[either in once daily \[qd\] or twice daily \[bid\]) on Day 1 to Day 7.
Experimental: Part 1: Cohort 1c - Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 18 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 1d - Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1d is optional and may be included at the discretion of the sponsor.
Experimental: Part 1: Cohort 1e - Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1e is optional and may be included at the discretion of the sponsor.
Experimental: Part 1: Cohort 2a - Participants (\>= 3 months and less than \[\<\] 6 months of age) will receive total daily dose of 1.5 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 2b - Participants (\>=3 months and \< 6 months of age) will receive total daily dose of 4.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 2c - Participants (\>= 3 months and \< 6 months of age) will receive total daily dose of 13.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7
Experimental: Part 1: Cohort 2d - Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2d is optional and may be included at the discretion of the sponsor.
Experimental: Part 1: Cohort 2e - Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2e is optional and may be included at the discretion of the sponsor.
Experimental: Part 1: Cohort 3a - Participants (greater than (\>) 1 month and \< 3 months of age) will receive total daily dose of 1 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 3b - Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 3 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 3c - Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 9 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.
Experimental: Part 1: Cohort 3d - Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3d is optional and may be included at the discretion of the sponsor.
Experimental: Part 1: Cohort 3e - Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3e is optional and may be included at the discretion of the sponsor.
Experimental: Part 2: Cohort f - Participants of all age groups will receive daily dose of JNJ-53718678 oral solution or placebo, either in a qd or a bid regimen on Days 1 to 7.
Treatment: Drugs: JNJ-53718678
JNJ-53718678 oral solution will be administered once or twice daily for 7 days.
Treatment: Drugs: Placebo
Placebo oral solution will be administered once or twice daily for 7 days.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Maximum Observed Plasma Concentration (Cmax) of JNJ-53718678
Query!
Assessment method [1]
0
0
The Cmax is the maximum observed plasma concentration.
Query!
Timepoint [1]
0
0
Days 1, 2 and 3
Query!
Primary outcome [2]
0
0
Trough Plasma Concentration (Ctrough) of JNJ-53718678
Query!
Assessment method [2]
0
0
The Ctrough 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.
Query!
Timepoint [2]
0
0
Days 1, 2 and 3
Query!
Primary outcome [3]
0
0
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Query!
Assessment method [3]
0
0
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval.
Query!
Timepoint [3]
0
0
Days 1, 2 and 3
Query!
Primary outcome [4]
0
0
Total Apparent Clearance (CL/F) of JNJ-53718678
Query!
Assessment method [4]
0
0
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Query!
Timepoint [4]
0
0
Days 1, 2 and 3
Query!
Primary outcome [5]
0
0
Apparent Volume of Distribution (Vd/F) of JNJ-53718678
Query!
Assessment method [5]
0
0
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed.
Query!
Timepoint [5]
0
0
Days 1, 2 and 3
Query!
Primary outcome [6]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [6]
0
0
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Query!
Timepoint [6]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [1]
0
0
Area Under the Viral Load-time Curve (VL AUC)
Query!
Assessment method [1]
0
0
VL will be determined by quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of nasal swabs. The VL AUC (copies. hour/ml) will be calculated based on the trapezoidal method.
Query!
Timepoint [1]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [2]
0
0
Amount of Viral Load Over Time
Query!
Assessment method [2]
0
0
VL (copies/ml) at each assessment timepoint where a nasal sample is obtained.
Query!
Timepoint [2]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [3]
0
0
Number of viral particles at Peak Viral Load
Query!
Assessment method [3]
0
0
Peak viral load (copies/ml) is a measure of the maximum number of viral particles present in nasal swabs.
Query!
Timepoint [3]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [4]
0
0
Time To Peak Viral Load
Query!
Assessment method [4]
0
0
Time (hours) to peak viral load will be reported.
Query!
Timepoint [4]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [5]
0
0
Number of Participants Reaching Undetectability of virus Between First Administration of Study Drug and Day 28
Query!
Assessment method [5]
0
0
Non-detectability of virus in nasal swabs between first administration of study drug and Day 28 will be reported.
Query!
Timepoint [5]
0
0
Day 1 to Day 28
Query!
Secondary outcome [6]
0
0
Total Number of Respiratory Syncytial Virus (RSV) Hospitalization Days from Admission to Discharge
Query!
Assessment method [6]
0
0
The total number of Respiratory Syncytial Virus (RSV) hospitalization days from admission to discharge will be reported.
Query!
Timepoint [6]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [7]
0
0
Total RSV Hospitalization Days with Supplemental Oxygen Requirement
Query!
Assessment method [7]
0
0
The total number of RSV Hospitalization Days with Supplemental Oxygen Requirement will be reported.
Query!
Timepoint [7]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [8]
0
0
The Number of days in Intensive care unit (ICU) due to RSV
Query!
Assessment method [8]
0
0
The number of days stayed in ICU due to RSV will be reported.
Query!
Timepoint [8]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [9]
0
0
Total Days of non-invasive ventilator support During RSV Hospitalization
Query!
Assessment method [9]
0
0
The total number of days with non-invasive ventilator support during RSV hospitalization will be reported.
Query!
Timepoint [9]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [10]
0
0
Total Days of Mechanical Ventilation During RSV Hospitalization
Query!
Assessment method [10]
0
0
The total number of days with Mechanical Ventilation during RSV hospitalization will be reported.
Query!
Timepoint [10]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [11]
0
0
Changes in Peripheral Capillary Oxygen Saturation (SpO2)
Query!
Assessment method [11]
0
0
The Percentage of Peripheral Capillary Oxygen Saturation (SpO2) will be assessed by the investigator during hospitalisation.
Query!
Timepoint [11]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [12]
0
0
Change from Baseline in Respiratory Rate
Query!
Assessment method [12]
0
0
The Respiratory rate (number of breaths per minute) will be assessed by the investigator and caregiver during hospitalisation.
Query!
Timepoint [12]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [13]
0
0
Change from Baseline in Body Temperature
Query!
Assessment method [13]
0
0
The body temperature (degrees Celcius) will be assessed by the investigator and caregiver during hospitalisation.
Query!
Timepoint [13]
0
0
Up to Follow-up (Day 28)
Query!
Secondary outcome [14]
0
0
Clinical Symptom Score
Query!
Assessment method [14]
0
0
The clinical symptom score will be assessed by the investigator (Clinician Outcome Assessment) and caregiver symptom Diary for each symptom. Clinical Symptom score ranges from 0 (best) to 4 (worst).
Query!
Timepoint [14]
0
0
Up to Follow-up (Day 28)
Query!
Eligibility
Key inclusion criteria
* Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
* Participant has been hospitalized for this suspected RSV infection
* Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally
* Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
* A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
Query!
Minimum age
1
Month
Query!
Query!
Maximum age
24
Months
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
* Participant has major congenital anomalies or known cytogenetic disorders
* Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
* Participant has known or suspected hepatitis B or C infection
* Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/12/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/11/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
45
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Geelong
Query!
Recruitment hospital [2]
0
0
- Hobart
Query!
Recruitment hospital [3]
0
0
- Westmead
Query!
Recruitment postcode(s) [1]
0
0
- Geelong
Query!
Recruitment postcode(s) [2]
0
0
- Hobart
Query!
Recruitment postcode(s) [3]
0
0
- Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Missouri
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Bahía Blanca
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
City of Buenos Aires
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Córdoba
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Anderlecht
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Bruxelles
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Charleroi
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Edegem
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Leuven
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Lier
Query!
Country [11]
0
0
Brazil
Query!
State/province [11]
0
0
Curitiba
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
Porto Alegre
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Ribeirao Preto
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
Rio de Janeiro
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
São Paulo
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Freiburg
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Hamm
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Heidelberg
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
München
Query!
Country [20]
0
0
Netherlands
Query!
State/province [20]
0
0
Hoofddorp
Query!
Country [21]
0
0
Netherlands
Query!
State/province [21]
0
0
Utrecht
Query!
Country [22]
0
0
Philippines
Query!
State/province [22]
0
0
Cebu City
Query!
Country [23]
0
0
Philippines
Query!
State/province [23]
0
0
Manila City
Query!
Country [24]
0
0
Spain
Query!
State/province [24]
0
0
Almeria
Query!
Country [25]
0
0
Spain
Query!
State/province [25]
0
0
Barcelona
Query!
Country [26]
0
0
Spain
Query!
State/province [26]
0
0
Esplugues de Llobregat
Query!
Country [27]
0
0
Spain
Query!
State/province [27]
0
0
Getafe
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Madrid
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Malaga
Query!
Country [30]
0
0
Spain
Query!
State/province [30]
0
0
Santiago de Compostela
Query!
Country [31]
0
0
Spain
Query!
State/province [31]
0
0
Sevilla
Query!
Country [32]
0
0
Spain
Query!
State/province [32]
0
0
Valencia
Query!
Country [33]
0
0
Sweden
Query!
State/province [33]
0
0
Göteborg
Query!
Country [34]
0
0
Sweden
Query!
State/province [34]
0
0
Linköping
Query!
Country [35]
0
0
Sweden
Query!
State/province [35]
0
0
Lund
Query!
Country [36]
0
0
Sweden
Query!
State/province [36]
0
0
Malmö
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Sciences Ireland UC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than \[\>\] 1 month to less than or equal to \[\<=\] 24 months of age) who are hospitalized with RSV infection.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02593851
Query!
Trial related presentations / publications
Martinon-Torres F, Rusch S, Huntjens D, Remmerie B, Vingerhoets J, McFadyen K, Ferrero F, Baraldi E, Rojo P, Epalza C, Stevens M. Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study. Clin Infect Dis. 2020 Dec 17;71(10):e594-e603. doi: 10.1093/cid/ciaa283.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Janssen Sciences Ireland UC Clinical Trial
Query!
Address
0
0
Janssen Sciences Ireland UC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02593851
Download to PDF