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

Janssen (J&J Innovative Medicine)

Status

Conditions: H7N9 Subtype of Influenza A Virus

Treatments: Drug: Pimodivir

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03834376

63623872FLZ4001 (Other Identifier)

CR108461

Details and patient eligibility

About

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.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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