Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection

October 27, 2020 updated by: Janssen Research & Development, LLC

Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection

The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Such access may be considered for eligible patients with serious/life-threatening diseases or conditions, where alternative treatments do not exist or have been exhausted.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has an H7N9 Influenza A infection
  • The patient has no known severe hepatic impairment

Exclusion Criteria:

- Any other Influenza A sub-strains other than H7N9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (ACTUAL)

February 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108461
  • 63623872FLZ4001 (OTHER: Janssen Research & Development, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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