Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
56-39 years
Phase:
PHASE2
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 v...
Detailed Description
RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis is that treatment of RSV-infected infants/children with lumicitabine (also known as JNJ-64041575 or ALS-008...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03332459
Start Date
January 5 2018
End Date
April 13 2020
Last Update
April 13 2021
Active Locations (4)
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1
Fukuyama City Hospital
Fukuyama, Japan, 721-8511
2
Hirosaki National Hospital
Hirosaki, Japan, 036-8545
3
National Hospital Organization Niigata National Hospital
Niigata, Japan, 945-8585
4
National Hospital Organization Beppu Medical Center
Ōita, Japan, 874-0011