search
Back to results

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

Primary Purpose

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
AB-PA01
Sponsored by
Armata Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2017
    Last Updated
    May 24, 2019
    Sponsor
    Armata Pharmaceuticals, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03395743
    Brief Title
    Individual Patient Expanded Access for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic
    Official Title
    Expanded Access Program for AB-PA01, an Investigational Anti-Pseudomonas Aeruginosa Bacteriophage Therapeutic, for the Treatment of Individual Patients With Serious or Immediately Life-threatening Infections Caused by Pseudomonas Aeruginosa
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Armata Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    AB-PA01
    Intervention Description
    AB-PA01 is an investigational bacteriophage therapeutic for treatment of Pseudomonas aeruginosa infections

    10. Eligibility

    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs