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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395769
Expanded Access Status : No longer available
First Posted : January 10, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Armata Pharmaceuticals, Inc.

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.


Intervention/treatment
Biological: AB-SA01

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access Program for AB-SA01, an Investigational Anti-Staphylococcus Aureus Bacteriophage Therapeutic, for the Treatment of Serious Infections Caused by Staphylococcus Aureus.

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: AB-SA01
    AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-


No Contacts or Locations Provided
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Responsible Party: Armata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03395769    
Other Study ID Numbers: AB-SA01-EAP01
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019