Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT03332459
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief 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
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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-008176) will decrease subsequent wheezing/asthma compared to placebo (looks like lumicitabine). The participants who have completed treatment course (lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in infants/children with a history of RSV infection. The participants will be assessed via monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: