Trials / Active Not Recruiting
Active Not RecruitingNCT04770779
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 258 (actual)
- Sponsor
- Agios Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The mitapivat group included 171 participants. The placebo group included 87 participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo Matching Mitapivat | Tablets |
| DRUG | Mitapivat | Tablets |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2024-04-11
- Completion
- 2029-06-01
- First posted
- 2021-02-25
- Last updated
- 2026-03-30
- Results posted
- 2025-05-25
Locations
75 sites across 19 countries: United States, Brazil, Bulgaria, Canada, Denmark, France, Germany, Greece, Italy, Lebanon, Malaysia, Netherlands, Saudi Arabia, Spain, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04770779. Inclusion in this directory is not an endorsement.