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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03395769|
Expanded Access Status : Available
First Posted : January 10, 2018
Last Update Posted : January 10, 2018
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 email@example.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.
|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.|
- Biological: AB-SA01
AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections
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): NCT03395769
|Contact: AmpliPhi Regulatory Affairsfirstname.lastname@example.org|