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

NCT ID: NCT03395769

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief 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 expandedaccess@ampliphibio.com 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

AB-SA01

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Accepts Healthy Volunteers: No

Sponsors

Armata Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AB-SA01-EAP01

Identifier Type: -

Identifier Source: org_study_id