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NCT04583280 · ClinicalTrials.gov registry record · Phase 3
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT04583280: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT04583280 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583280, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
Primary Outcome
RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=wors
Interventions
- DRUG Placebo
- DRUG Rilematovir
- DRUG Rilematovir X mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-09-06 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 3 |
Why NCT04583280 stopped before completion
NCT04583280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04583280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04583280 about?
NCT04583280 is a clinical study titled "A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)". The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
What is the current status of trial NCT04583280?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2021-09-06. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT04583280?
The interventions under investigation include: Placebo (DRUG), Rilematovir (DRUG), Rilematovir X mg/kg (DRUG).
Who is sponsoring clinical trial NCT04583280?
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 NCT04583280's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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