At a glance
ClinicalIndex Comparison RecordPhase 3Active· 194 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 Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)
In Brief
A Phase 3 clinical trial evaluating Placebo Matching Mitapivat and Mitapivat for Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia. Active but no longer recruiting, targeting 194 participants across 68 sites in 18 countries.
Detailed Summary
The primary purpose of this study was to compare the effect of mitapivat versus placebo on hemolytic anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Bulgaria, Canada, Denmark, France, 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 StartDec 2021
Primary CompletionNov 2023
TodayJul 2026
Study CompletionDec 2028
First PostedFeb 25, 2021
Enrollment StartDec 20, 2021
Primary CompletionNov 13, 2023
Study CompletionDec 1, 2028
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.4 years ago
Interventions
Placebo Matching Mitapivatdrug
Tablets
Mitapivatdrug
Tablets