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

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ClinicalTrials.gov Identifier: NCT03834376
Expanded Access Status : No longer available
First Posted : February 8, 2019
Last Update Posted : October 28, 2020
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment
H7N9 Subtype of Influenza A Virus Drug: Pimodivir

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

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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

No Contacts or Locations Provided
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03834376    
Other Study ID Numbers: CR108461
63623872FLZ4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases