Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic

NCT03395743 | Unknown

• 1 other identifier: AB-PA01-EAP01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, AB-PA01, for patients with serious or immediately life-threatening Pseudomonas aeruginosa 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-PA01 BIOLOGICAL

AB-PA01 is an investigational bacteriophage therapeutic for treatment of Pseudomonas aeruginosa infections

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Armata Pharmaceuticals, Inc.: lead

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 10, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05