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Individual Patient Expanded Access for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic

NCT03395769 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-05-29

No results posted yet for this study

Summary

The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-SA01, for patients with serious or immediately life-threatening Staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under FDA's Expanded Access regulations and criteria set forth by AmpliPhi Biosciences Corporation.

To be considered for expanded access, the request should be submitted to AmpliPhi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. Treating physicians should contact AmpliPhi by emailing [email protected] with "Expanded Access Request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition.

Any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.

Interventions

BIOLOGICAL

AB-SA01

AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections

Sponsors & Collaborators

  • Armata Pharmaceuticals, Inc.

    lead INDUSTRY

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395769 on ClinicalTrials.gov