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

NCT03834376 | Unknown

• 2 other identifiers: CR10846163623872FLZ4001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

H7N9 Subtype of Influenza A Virus

Interventions

Pimodivir DRUG

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

Also known as: JNJ-63623872

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Any other Influenza A sub-strains other than H7N9

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Interventions

pimodivir

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 8, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10