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Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04221412
Expanded Access Status : No longer available
First Posted : January 9, 2020
Last Update Posted : May 16, 2022
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

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.

Condition or disease Intervention/treatment
Respiratory Syncytial Virus Drug: JNJ-53718678

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: JNJ-53718678 RSV Pre-Approval Access_Single Patient Access (SPR) for Patients Diagnosed With RSV

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Intervention Details:
  • Drug: JNJ-53718678
    JNJ-53718678 will be administered as directed by treating physician.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04221412

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Dummy, Hungary, 99999
Dummy, Italy, 99999
Dummy, Spain, 99999
Dummy, Sweden, 99999
United Kingdom
Dummy, United Kingdom, 99999
Sponsors and Collaborators
Janssen Sciences Ireland UC
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Sciences Ireland UC Identifier: NCT04221412    
Other Study ID Numbers: CR108653
53718678RSV4001 ( Other Identifier: Janssen Sciences Ireland UC )
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022