A long-term follow-up of study 64041575RSV2004 to investigate the effects of lumicitabine (JNJ-64041575) in infants and children with a history of Respiratory Syncytial Virus infection

• Register: EUCTR
• Last refreshed on: 8 June 2020
• Main ID: EUCTR2016-002095-26-FR
• Date of registration: 04/09/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A long-term follow-up of study 64041575RSV2004 to investigate the effects of lumicitabine (JNJ-64041575) 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 - PLUM Follow-up
• Date of first enrolment: 08/02/2018
• Target sample size: 63
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002095-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: This study is an observational long-term follow-up of Study 64041575RSV2004; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female infants and children who were previously randomized in Study 64041575RSV2004 for the treatment of RSV infection and who completed the planned course of the study drug and the last study-related visit of Study 64041575RSV2004.
2. The subject’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 subject to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 63
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. The subject’s legally acceptable representative, ie, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator.
2. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

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

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

Secondary Objective: The secondary objectives are to evaluate during the follow-up period in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004:
• The frequency of wheezing over time.
• The frequency of wheezing episodes over time.
• The long-term safety of lumicitabine.
• The frequency and type of respiratory infections.
• Medical resource utilization.

Timepoint(s) of evaluation of this end point: Monitored throughout the study

Main Objective: The primary objectives are to evaluate in infants and children who have been treated with lumicitabine or placebo in Study 64041575RSV2004 during the follow-up period and within 2 years after the RSV infection:
• The incidence of the clinical diagnosis of asthma.
• The frequency of wheezing.

Primary end point(s): • Clinical diagnosis of asthma within the first 2 years after the RSV infection, as diagnosed by a physician and reported by the parent/caregiver.
• Percentage of wheezing days within the first 2 years after the RSV infection, based on information reported by the parent/caregiver.

Secondary Outcome(s)

Secondary end point(s): • Percentage of wheezing days per month after the RSV infection, based on information reported by the parent/caregiver.
• Number of wheezing episodes after the RSV infection, based on information reported by the parent/caregiver.
• Incidence of reportable AEs and SAEs among subjects, based on information reported by the parent/caregiver and judged by the investigator. Reportable AEs include AEs related to respiratory illnesses and AEs considered at least possibly related to lumicitabine or placebo by the investigator.
• Number and type of respiratory infections among subjects, based on information reported by the parent/caregiver.
• Medical resource utilization including the number of medical visits, emergency room visits, and hospitalizations, all for respiratory conditions only, based on information reported by the parent/caregiver.

Timepoint(s) of evaluation of this end point: Monitored throughout the study

Secondary ID(s)

2016-002095-26-GB

64041575RSV2002

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date: 08/02/2018
Contact: