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

N/ANo Longer AvailableNCT03834376

Janssen Research & Development, LLC

Overview

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 Type

EXPANDED_ACCESS

Conditions

H7N9 Subtype of Influenza A Virus

Interventions

PimodivirDRUG

Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram \[mg\]) over a time period of 5 days.

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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