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

NCT05777993

Enrolling By InvitationPhase 4

Sponsor: Agios Pharmaceuticals, Inc.

Conditions: Pyruvate Kinase Deficiency, Anemia, Hemolytic, Sickle Cell Disease, Thalassemia

Interventions: Mitapivat

Countries: Belgium, Brazil, Canada, France, Israel, Japan, Turkey (Türkiye), United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Known allergy or other contraindication to mitapivat or its inactive ingredients as defined in the current investigator brochure (IB).
* 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).

Locations (23)

Anderlecht, Brussels Capital, Belgium
Porto Alegre, Rio Grande do Sul, Brazil
Campinas, São Paulo, Brazil
Rio de Janeiro, Brazil
Santo André, Brazil
São Paulo, Brazil
São Paulo, Brazil
São Paulo, Brazil
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Marseille, Bouches-du-Rhône, France
Bordeau, France
Créteil, France
Lyon, France
Paris, France
Paris, France
Haifa, Ḥeifā, Israel
Safed, Ḥeifā, Israel
Sendai, Miyagi, Japan
Kyoto, Japan
Ōta-ku, Japan
Seyhan, Adana, Turkey (Türkiye)
Manchester, United Kingdom