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Trial record 2 of 2 for:    elamipretide | Barth syndrome

An Intermediate Size Expanded Access Protocol of Elamipretide

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: NCT04689360
Expanded Access Status : Available
First Posted : December 30, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

Tracking Information
First Submitted Date December 23, 2020
First Posted Date December 30, 2020
Last Update Posted Date November 8, 2021
 
Descriptive Information
Brief Title An Intermediate Size Expanded Access Protocol of Elamipretide
Brief Summary Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program. The treating physician must contact StealthBiotherapeutics using the Expanded Access Program Contacts provided. Elamipretide will only be made available after careful review of an individual request submitted by the treating physician. The initiation and conduct of the treatment with elamipretide for an individual patient, and compliance with this treatment guideline, will be under the full and sole responsibility of the treating physician.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: elamipretide
Elamipretide is an aromatic-cationic tetrapeptide that readily penetrates cell membranes and transiently localizes to the inner mitochondrial membrane.
Other Name: MTP-131
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: Donna Cowan 617.600.6888 donna.cowan@stealthbt.com
Contact: Donna Cowan access@stealthbt.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04689360
Current Responsible Party Stealth BioTherapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor Stealth BioTherapeutics Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Stealth BioTherapeutics Inc.
Verification Date November 2021