A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non–Transfusion-Dependent Alpha or Beta Thalassemia (ENERGIZE)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512745-16-00

Acronym

AG348-C-017

Enrollment

Registered

2024-07-23

Start date

2022-04-13

Completion date

Unknown

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non–Transfusion-Dependent Alpha- or Beta-Thalassemia

Brief summary

Hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline

Interventions

DRUGPlacebo for Mitapivat

DRUGMITAPIVAT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline	—

Countries

Bulgaria, Denmark, France, Greece, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026