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Active (not recruiting) Phase 3 2024-512745-16-00

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)

Phase 3 – large-scale trial before approval
Conditions: Non–Transfusion-Dependent Alpha- or Beta-Thalassemia

Sponsor: Agios Pharmaceuticals Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Hemoglobin (Hb) response, defined as a ≥1.0 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 86 participants
Interventions
Placebo for Mitapivat
Drug
MITAPIVAT
Drug
Locations 7
Bulgaria (1)
Denmark (1)
France (1)
Greece (1)
Italy (1)
Netherlands (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.07.2024
Registry ID
2024-512745-16-00
Source
euclinicaltrials.eu
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