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

Primary Purpose

H7N9 Subtype of Influenza A Virus

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Pimodivir
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for H7N9 Subtype of Influenza A Virus

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2019
    Last Updated
    October 27, 2020
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03834376
    Brief Title
    Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection
    Official Title
    Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Research & Development, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    H7N9 Subtype of Influenza A Virus

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pimodivir
    Other Intervention Name(s)
    JNJ-63623872
    Intervention Description
    Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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