Clinical Trials List
2017-12-15 - 2021-08-25
Phase II
Terminated3
ICD-10B97.4
Respiratory syncytial virus as the cause of diseases classified elsewhere
ICD-10B97
Viral agents as the cause of diseases classified elsewhere
ICD-9079.6
Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site
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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Trial Applicant
Syneos Health
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 黃競瑩 Division of Pediatrics
- Nan-Chang Chiu Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Taiwan National PI
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Nan-Chang Chiu Division of Pediatrics
- 黃競瑩 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection [ Time Frame: Up to 2 years ]
Percentage of participants with asthma diagnosed by physician were reported.
Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection [ Time Frame: Up to 2 years ]
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.
Inclution 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
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
The Estimated Number of Participants
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Taiwan
1 participants
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Global
180 participants
