Continued Access to Mitapivat for Earlier Study Participants
Gives continued mitapivat to adults from an earlier Agios study with blood disorders.
Plain-language title generated from the registry record
Registry title: A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Key facts
- Where
- Hamilton and Toronto, CanadaSee the 2 sites
- Phase
- Phase 4
Where in Canada
- McMaster Centre for Transfusion Medicine McMaster UniversityHamilton, CanadaNo longer taking part
- University Health NetworkToronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Agios Pharmaceuticals, Inc.
- Trial code
- NCT05777993EU 2026-526243-35-00
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
A Rollover Study to Provide Continued Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
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.
Inclusion: Participating in an Agios-sponsored study of mitapivat and deriving clinical benefit from ongoing mitapivat treatment, in the opinion of the Investigator; For women of childbearing potential (WOCBP), must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of providing informed consent/assent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method; Written informed consent/assent from the participant (or their legally authorized representative, parent[s], or legal guardian) before any study-related procedures are conducted, and participants must be willing to comply with all study procedures for the duration of the study; Agrees not to participate in other interventional clinical studies, including other studies of mitapivat, during participation in this study.
Exclusion: Any medical, hematologic, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:; Participants who are institutionalized by regulatory or court order; Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor); Known allergy or other contraindication to mitapivat or its inactive ingredients as defined in the current investigator brochure (IB).