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

H7N9 Subtype of Influenza A Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03834376
• Other study ID #: CR108461
• Secondary ID: 63623872FLZ4001
• Status: No longer available

Study information

• Verified date: October 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• H7N9 Subtype of Influenza A Virus
• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC