Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583280
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2020-10-09
Brief Title:
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus RSV
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children 28 Days to 5 Years of Age and Subsequently in Neonates 28 Days of Age Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus RSV
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Janssen made the strategic decision to discontinue the DAISY study This decision is not based on any safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAISY
Brief 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
Detailed Description:
Respiratory syncytial virus RSV a negative-stranded ribonucleic acid RNA virus belonging to the Pneumoviridae family is considered the most important cause of acute lower respiratory tract infection LRTI in infants and young children In most patients RSV results in upper respiratory tract infection URTI eliciting common cold-like symptoms which might last up to 2 weeks and are usually self-limiting RSV-related LRTI is a major cause of hospital admissions and death in young children worldwide Rilematovir is an investigational small molecule RSV fusion inhibitor This study aims to evaluate the efficacy and safety of rilematovir in hospitalized infants and children greater than or equal to 28 days to less than or equal to 5 years and subsequent to completion of the neonatal substudy in hospitalized neonates born at term less than 28 days of age with RSV infection The study will include a Screening Period a Treatment Period and a Follow-up Period The total study duration for each participant will be approximately 36 days Screening included The efficacy assessments include evaluation under the RRS and the safety assessments include evaluations of physical examinations vital signs electrocardiograms clinical laboratory tests and adverse events
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002023-11 | EUDRACT_NUMBER | None | None |
| 53718678RSV3001 | OTHER | Janssen Research Development LLC | None |