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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
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
Secondary ID [1] 0 0
2016-002095-26
Secondary ID [2] 0 0
CR108375
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
Assessment method [1] 0 0
Percentage of participants with asthma diagnosed by physician were reported.
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Assessment method [1] 0 0
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%.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Assessment method [2] 0 0
Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Number of Participants With Reportable Adverse Events (AEs)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of Respiratory Infections Per Participant
Assessment method [5] 0 0
The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Number of Participants With Medical Encounters
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Up to 2 years

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
Minimum age
56 Days
Maximum age
39 Months
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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 administering 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2020
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Fukuyama
Country [2] 0 0
Japan
State/province [2] 0 0
Hirosaki
Country [3] 0 0
Japan
State/province [3] 0 0
Niigata
Country [4] 0 0
Japan
State/province [4] 0 0
Oita

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03332459