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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04221412
Expanded Access Status : Available
First Posted : January 9, 2020
Last Update Posted : February 10, 2021
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

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

Information from the National Library of Medicine

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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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Contact: Contact 1-800-JANSSEN (1-800-526-7736)

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: February 10, 2021
Last Verified: February 2021