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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03332459
Registration number
NCT03332459
Ethics application status
Date submitted
16/10/2017
Date registered
6/11/2017
Date last updated
13/04/2021
Titles & IDs
Public title
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
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Scientific title
A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
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Secondary ID [1]
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2016-002095-26
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Secondary ID [2]
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CR108375
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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 Virus Infections
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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: Lumicitabine - Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.
Placebo comparator: Placebo - Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.
Treatment: Drugs: Lumicitabine
Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
Treatment: Drugs: Placebo
Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
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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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Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
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Assessment method [1]
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Percentage of participants with asthma diagnosed by physician were reported.
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Timepoint [1]
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Up to 2 years
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Primary outcome [2]
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Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection
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Assessment method [2]
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Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\*100.
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Timepoint [2]
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Up to 2 years
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Secondary outcome [1]
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Percentage of Wheezing Days in Participants Per Month After RSV Infection
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Assessment method [1]
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Percentage of wheezing days in participants per month after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days per month was calculated by number of days reported in that period with wheezing, using last day - first day + 1 for reported days of wheezing and multiplied by 100%.
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Timepoint [1]
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Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
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Secondary outcome [2]
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Number of Wheezing Episodes in Participants Per Month After the RSV Infection
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Assessment method [2]
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Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.
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Timepoint [2]
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Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
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Secondary outcome [3]
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Number of Participants With Reportable Adverse Events (AEs)
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Assessment method [3]
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Number of participants with reportable AEs were reported. The following AEs were considered reportable (within the context of this study): respiratory illness AEs, including subsequent RSV infections, adverse events considered at least possibly related to study treatment (lumicitabine or placebo, as received in study 64041575RSV2004), and serious adverse events.
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [4]
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SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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Number of Respiratory Infections Per Participant
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Assessment method [5]
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The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
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Timepoint [5]
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Up to 2 years
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Secondary outcome [6]
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Number of Participants With Medical Encounters
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Assessment method [6]
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Number of participants with medical encounters (hospital inpatient department visits, hospital outpatient department visits, medical practitioner office visits) was reported based on information reported by the parent/caregiver.
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Timepoint [6]
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Up to 2 years
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Eligibility
Key inclusion criteria
* Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004
* The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study
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Minimum age
56
Days
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Maximum age
39
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
* The participants legally acceptable representative, i.e, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
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Study design
Purpose of the study
Other
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Allocation to intervention
Non-randomised 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 administering 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
Completed
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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
5/01/2018
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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
13/04/2020
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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]
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Japan
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State/province [1]
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Fukuyama
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Country [2]
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Japan
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State/province [2]
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Hirosaki
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Country [3]
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Japan
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State/province [3]
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Niigata
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Country [4]
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Japan
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State/province [4]
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Oita
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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 long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).
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Trial website
https://clinicaltrials.gov/study/NCT03332459
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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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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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 are available at
https://clinicaltrials.gov/study/NCT03332459
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