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

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ClinicalTrials.gov Identifier: NCT03395743
Expanded Access Status : Available
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
AmpliPhi Biosciences Corporation

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.


Intervention/treatment
Biological: AB-PA01

Study Type : Expanded Access
Expanded Access Type : Individual Patients
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: AB-PA01
    AB-PA01 is an investigational bacteriophage therapeutic for treatment of Pseudomonas aeruginosa infections

Information from the National Library of Medicine

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

Inclusion Criteria:

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395743


Contacts
Contact: AmpliPhi Regulatory Affairs 858-829-0829 expandedaccess@ampliphibio.com

Sponsors and Collaborators
AmpliPhi Biosciences Corporation

Responsible Party: AmpliPhi Biosciences Corporation
ClinicalTrials.gov Identifier: NCT03395743     History of Changes
Other Study ID Numbers: AB-PA01-EAP01
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections