A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study

Sponsor
Agios Pharmaceuticals, Inc.
Study ID
NCT05777993
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Mar 21, 2023
Start date
Jul 6, 2023
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mitapivat
    Participants will continue to receive mitapivat at the same dose regimen they were receiving at the final visit of their antecedent study.

Primary Outcome Measure

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 ]

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