The primary objective of the study is to provide continued access to participants who are deriving clinical benefit from ongoing mitapivat treatment in an Agios-sponsored mitapivat study, in the opinion of the Investigator.
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
59
Tablets, granules
Hôpital Erasme
Anderlecht, Brussels Capital, Belgium
Not applicable as this protocol is to provide an option for continued access to mitapivat for participants who have previously participated in an Agios-sponsored mitapivat study
Time frame: Not Applicable - Study Completion
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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