Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants
JNJ-53718678 RSV Pre-Approval Access_Single Patient Access (SPR) for Patients Diagnosed With RSV
2 other identifiers
expanded_access
N/A
0 countries
N/A
Brief Summary
The purpose of this pre-approval access program is to provide treatment to immunocompromised participants with serious/life-threatening diseases or conditions (Respiratory Syncytial Virus \[RSV\] infection) and to collect the safety data to understand the safety profile of JNJ-53718678.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedAugust 29, 2022
August 1, 2022
January 7, 2020
August 24, 2022
Conditions
Interventions
JNJ-53718678 will be administered as directed by treating physician.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 9, 2020
Last Updated
August 29, 2022
Record last verified: 2022-08