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NCT03656510 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 246
- Enrollment target
NCT03656510: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT03656510 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 246 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656510, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 246 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants \[Cohort 1\] or outpatients \[Cohort 2\]).
Primary Outcome
RSV viral load AUC from immediately prior to first dose of study drug through Day 5 was determined. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens. As planned, combined data for both the cohorts was collected, analyzed and reported for this outcome measure.
Interventions
- DRUG Placebo
- DRUG JNJ-53718678
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2022-04-18 |
| Phase | Phase 2 |
Why NCT03656510 stopped before completion
NCT03656510 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03656510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03656510 about?
NCT03656510 is a clinical study titled "Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection". The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respira...
What is the current status of trial NCT03656510?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2018-11-29. Estimated completion is 2022-04-18.
What interventions are being tested in trial NCT03656510?
The interventions under investigation include: Placebo (DRUG), JNJ-53718678 (DRUG).
Who is sponsoring clinical trial NCT03656510?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656510's enrollment target sits among peer trials
246 234th of 2000 higher than 1,767 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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