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

NCT ID: NCT04221412

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Respiratory Syncytial Virus

Interventions

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JNJ-53718678

JNJ-53718678 will be administered as directed by treating physician.

Intervention Type DRUG

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Other Identifiers

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53718678RSV4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108653

Identifier Type: -

Identifier Source: org_study_id

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