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NCT04770753 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
A Phase 3 study of Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia, sponsored by Agios Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT04770753: Active Phase 3 study of Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia, sponsored by Agios Pharmaceuticals.
NCT04770753 is a Phase 3 study of Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia that is active but no longer recruiting, run by Agios Pharmaceuticals. The registered enrollment target is 194 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04770753, a Phase 3 study of Non-Transfusion-dependent Alpha-Thalassemia and Non-Transfusion-dependent Beta-Thalassemia, is active but no longer recruiting, sponsored by Agios Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Mitapivat
- DRUG Placebo Matching Mitapivat
Study Locations (20)
Other
- Universidade de Caxias do Sul - Caxias do Sul
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP - Ribeirão Preto
- HEMORIO Instituto Nacional de Hematologia - Rio de Janeiro
- Praxis Pesquisa Medica - Santo André
- GSH Banco de Sangue de São Paulo - São Paulo
- Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo - São Paulo
- MHAT "Dr. Nikola Vasiliev" AD - Kyustendil
- SHATHD Sofia - Sofia
- Toronto General Hospital, University Health Network - Toronto
- Rigshospitalet - Copenhagen
- CHU Hôpital Henri Mondor - Créteil
- Hopital Edouard Herriot, CHU de Lyon - Lyon
- Laiko General Hospital - Athens
- Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School - Athens
California
- San Diego Hospital, UC San Diego Health - La Jolla
- Stanford Medicine - Palo Alto
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Weill Cornell Medical Center - New York
North Carolina
- Duke University Medical Center - Durham
Pennsylvania
- Penn Medicine - University of Pennsylvania Health System - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770753
The ClinicalTrials.gov registry entry for NCT04770753 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). The listed sponsor is Agios Pharmaceuticals, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Non-Transfusion-dependent Alpha-Thalassemia appearing as the primary indexed condition, and to 2 interventions - of which Mitapivat is the first listed.
NCT04770753 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04770753 about?
NCT04770753 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)". 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).
What is the current status of trial NCT04770753?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2021-12-20. Estimated completion is 2028-12.
What conditions does trial NCT04770753 study?
This clinical trial studies the following conditions: Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia.
What interventions are being tested in trial NCT04770753?
The interventions under investigation include: Mitapivat (DRUG), Placebo Matching Mitapivat (DRUG).
Who is sponsoring clinical trial NCT04770753?
This trial is sponsored by Agios Pharmaceuticals, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04770753 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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