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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03834376
Enrollment
Unknown
Registered
2019-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H7N9 Subtype of Influenza A Virus

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.

Interventions

DRUGPimodivir

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

Sponsors

Janssen Research & Development, LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026