CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Lumicitabine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03332459
NCT03332459Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Nov 6, 2017·Updated Apr 13, 2021

In Brief

A Phase 2 clinical trial evaluating Lumicitabine and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 7 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 6, 2017
Enrollment StartJan 5, 2018
Primary CompletionApr 13, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.7 years ago

Interventions

Lumicitabinedrug

Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.

Placebodrug

Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.