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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 : Available
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03834376


Contacts
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Contact: Contact 1-800-JANSSEN (1-800-526-7736) Janssenmedinfo@its.jnj.com

Sponsors and Collaborators
Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03834376     History of Changes
Other Study ID Numbers: CR108461
63623872FLZ4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases