A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

November 13, 2023

Study Completion Date

December 31, 2028

Conditions
Non-Transfusion-dependent Alpha-ThalassemiaNon-Transfusion-dependent Beta-Thalassemia
Interventions
DRUG

Placebo Matching Mitapivat

Tablets

DRUG

Mitapivat

Tablets

Trial Locations (68)

1756

SHATHD Sofia, Sofia

2100

Rigshospitalet, Copenhagen

2500

"MHAT Dr. Nikola Vasiliev AD", Kyustendil

4545

Thalassemia Centre Dubai, Dubai

9999

Chronic Care Center, Beirut

10043

A.O.U. San Luigi Gonzaga, Orbassano

10330

King Chulalongkorn Memorial Hospital, Pathum Wan

10400

Phramongkutklao Hospital, Bangkok

Ramathibodi Hospital, Bangkok

10700

Faculty of Medicine Siriraj Hospital, Bangkok

10990

Hospital Pulau Pinang, Pulau Pinang

14611

King Abdullah International Medical Research Center, Riyadh

16128

Ente Ospedaliero Ospedali Galliera, Genova

19104

Penn Medicine - University of Pennsylvania Health System, Philadelphia

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

25100

Hospital Tengku Ampuan Afzan, Kuantan

26504

University General Hospital of Patras, Rio

28046

Hospital Universitario La Paz, Madrid

30120

Hospital Universitario Virgen Arrixaca, Murcia

34093

Istanbul University Faculty of Medicine, Fatih

35040

Ege University Faculty of Medicine, Bornova

36428

King Abdulaziz Hospital - Al Ahsa, Al Mubarraz

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

40447

China Medical University, Taiwan, Taichung

41013

Hospital Universitario Virgen del Rocío, Seville

41124

A.O.U Di Modena, Modena

44124

Ospedale Sant'Anna, Ferrara

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

50300

Hospital Tunku Azizah, Kuala Lumpur

65000

Naresuan University Hospital, Mueang Phitsanulok

68000

Hospital Ampang, Ampang

69003

Hopital Edouard Herriot, CHU de Lyon, Lyon

72100

"Ospedale A. Perrino - Brindisi", Brindisi

80100

Hospital Sultanah Aminah Johor Bahru, Johor Bahru

80131

"A.O.R.N. A. Cardarelli", Napoli

80138

AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli, Napoli

88586

Hospital Queen Elizabeth, Kota Kinabalu, Kota Kinabalu

92093

San Diego Hospital, UC San Diego Health, La Jolla

93586

Hospital Umum Sarawak, Kuching

94010

CHU Hôpital Henri Mondor, Créteil

94304-1601

Stanford Medicine, Palo Alto

02114-2696

Massachusetts General Hospital, Boston

10065-4870

Weill Cornell Medical Center, New York

27710-3038

Duke University Medical Center, Durham

95070-560

Universidade de Caxias do Sul, Caxias do Sul

14051-260

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto

20211-030

HEMORIO Instituto Nacional de Hematologia, Rio de Janeiro

09090-790

Praxis Pesquisa Medica, Santo André

04006-002

GSH Banco de Sangue de São Paulo, São Paulo

05403-000

Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas da Faculdade de Medicina da Universidad de São Paulo, São Paulo

M5G 2C4

Toronto General Hospital, University Health Network, Toronto

115 26

Laiko General Hospital, Athens

115 27

Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School, Athens

546 42

Ippokrateio General Hospital, Thessaloniki

09121

Ospedale Pediatrico Microcitemico, Cagliari

05460

Hospital Sultanah Bahiyah, Alor Star

3015 GD

Erasmus MC, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

08035

Hospital Universitario Vall d'Hebron, Barcelona

01130

Acibadem Adana Hospital, Adana

07059

Akdeniz University Faculty of Medicine, Antalya

01330

Çukurova University, Balcalı

06230

Hacettepe University, Mersin

Unknown

Burjeel Medical City, Abu Dhabi

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge

M13 9WL

Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester

NW1 2PG

University College London, London

W12 OHS

Imperial College Healthcare NHS Trust - Hammersmith Hospital, London

Sponsors
All Listed Sponsors
lead

Agios Pharmaceuticals, Inc.

INDUSTRY