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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.
 
ClinicalTrials.gov Identifier: NCT04221412
Expanded Access Status : Available
First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Sciences Ireland UC

Tracking Information
First Submitted Date January 7, 2020
First Posted Date January 9, 2020
Last Update Posted Date January 9, 2020
 
Descriptive Information
Brief Title Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants
Official Title JNJ-53718678 RSV Pre-Approval Access_Single Patient Access (SPR) for Patients Diagnosed With RSV
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Respiratory Syncytial Virus
Intervention Drug: JNJ-53718678
JNJ-53718678 will be administered as directed by treating physician.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Eligibility Criteria Not Provided
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Contacts
Contact: Contact 1-800-JANSSEN (1-800-526-7736) Janssenmedinfo@its.jnj.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04221412
Other Study ID Numbers CR108653
53718678RSV4001 ( Other Identifier: Janssen Sciences Ireland UC )
Responsible Party Janssen Sciences Ireland UC
Study Sponsor Janssen Sciences Ireland UC
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Sciences Ireland UC
Verification Date January 2020