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NCT05935202: SATISFY

Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies

Not yet recruiting Phase 2 Last updated 26 December 2023
What this trial tests

Phase 2 trial testing Mitapivat sulfate in Hereditary Red Blood Cell Disorder (Disorder) in 25 participants. Not yet recruiting.

Timeline
21 December 2023
Primary endpoint
15 July 2025
15 December 2026

Quick facts

Lead sponsorEuroBloodNet Association
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date21 December 2023
Primary completion15 July 2025
Estimated completion15 December 2026
Sites2 locations across Denmark, Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

EuroBloodNet Association

Who can join

Adults 18 to 99, any sex, with Hereditary Red Blood Cell Disorder (Disorder). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective exploratory multicentre pilot study designed to study the safety and efficacy of mitapivat in RBC membranopathies and CDAII

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Designing a single-arm phase 2 clinical trial of mitapivat for adult patients with erythrocyte membranopathies (SATISFY): a framework for interventional trials in rare anaemias - pilot study protocol.
    Glenthøj A, van Beers EJ, van Wijk R, Rab MAE, et al · · 2024 · cited 2× · PMID 39079928 · DOI 10.1136/bmjopen-2023-083691
  2. Post-translational Modifications in Proteins: Prediction Methods, Biological Functions, and Diseases.
    Zhang S, Li J, Chen M, Huang H. · · 2026 · PMID 41978829 · DOI 10.1002/mco2.70729

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