The purpose of this study is to provide continued access to mitapivat for participants who completed an Agios-sponsored mitapivat study (antecedent) and do not have commercial access to mitapivat.
Participants will continue the mitapivat dose regimen that they were receiving at the final visit of their antecedent study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Tablets
McMaster Centre for Transfusion Medicine McMaster University
Hamilton, Ontario, Canada
Tohoku University Hospital
Sendai, Miyagi, Japan
Kyoto Katsura Hospital
Kyoto, Japan
Toho University - Omori Medical Center
Ōta-ku, Japan
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 6.2 years
Percentage of Participants With AEs and SAEs, Graded by Severity
The severity of all AEs will be graded by the Investigator according to Version 4.03 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) on a 5-point severity scale (Grade 1 through Grade 5) where Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening and Grade 5 is fatal.
Time frame: Up to approximately 6.2 years
Percentage of Participants With AEs Considered by the Investigator to be Related to Study Drug
Time frame: Up to approximately 6.2 years
Percentage of Participants With SAEs Considered by the Investigator to be Related to Study Drug
Time frame: Up to approximately 6.2 years
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