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

• Conditions: H7N9 Subtype of Influenza A Virus

• Registration Number: NCT03834376
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-05
• Study First Posted: 2019-02-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Any other Influenza A sub-strains other than H7N9

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Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified