At a glance
ClinicalIndex Comparison RecordPhase 3Active· 258 enrolled
Drug / intervention
Placebo Matching Mitapivat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE-T)
In Brief
A Phase 3 clinical trial evaluating Placebo Matching Mitapivat and Mitapivat for Transfusion-dependent Alpha-Thalassemia and Transfusion-dependent Beta-Thalassemia. Active but no longer recruiting, targeting 258 participants across 75 sites in 19 countries.
Detailed Summary
The primary objective of this study was to compare the effect of mitapivat versus placebo on transfusion burden in participants with α- or β-transfusion-dependent thalassemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Bulgaria, Canada, Denmark, France, Germany, Greece, Italy, Lebanon, Malaysia, Netherlands, Saudi Arabia, Spain, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Collaborators--
Timeline
Phase 3Active
202120222023202420252026202720282029
First PostedFeb 2021
Enrollment StartNov 2021
Primary CompletionApr 2024
TodayJul 2026
Study CompletionJun 2029
First PostedFeb 25, 2021
Enrollment StartNov 30, 2021
Primary CompletionApr 11, 2024
Study CompletionJun 1, 2029
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.4 years ago
Interventions
Placebo Matching Mitapivatdrug
Tablets
Mitapivatdrug
Tablets