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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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H7N9 Subtype of Influenza A Virus

Interventions

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Pimodivir

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

Intervention Type DRUG

Other Intervention Names

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JNJ-63623872

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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63623872FLZ4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108461

Identifier Type: -

Identifier Source: org_study_id